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Recall: Blood pressure medication recall over cancer risk expanded (Updated 24th Sept, 2019 in last post)


Arcadia
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From FDA https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm

Torrent further expands its voluntary recall of losartan

Update [1/23/2019Torrent Pharmaceuticals is further expanding its voluntary recall to include six additional lots of losartan potassium and hydrochlorothiazide combination tablets, for a total of 16 lots of losartan-containing medicines. This recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited.

Torrent is only recalling lots of losartan-containing medication containing NDEA above the interim acceptable intake limits of 0.27 parts per million (ppm).

The agency also updated the list of losartan medications under recall.

Irbesartan distributed by Solco Healthcare voluntarily recalled

Update [1/18/2019] FDA is alerting patients and health care professionals to a voluntary recall of one lot of irbesartan and seven lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare LLC, a Prinston Pharmaceutical Inc. subsidiary. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the irbesartan active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals (ZHP).

Solco is only recalling lots of irbesartan-containing medication where NDEA has been detected above the interim limit of 0.088 parts per million. FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin receptor II blockers (ARBs).

The agency also updated the list of irbesartan products under recall.

 

FDA alerts patients and health care professionals to Aurobindo’s recall of valsartan medication due to NDEA

Update [1/2/2019] FDA is alerting patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. Aurobindo is recalling amlodipine and HCTZ only in combination medications containing valsartan. Neither amlodipine nor HCTZ is currently under recall by itself.

Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim acceptable daily intake level of 0.083 parts per million.

The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above interim acceptable daily intake levels.

FDA also updated the list of valsartan products under recall and the list of valsartan products not under recall.

FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. Some ARBs contain no NDMA or NDEA.”

quick links:

“The agency has updated lists for all three kinds of drugs affected by the recalls.

  • For valsartan-containing products currently recalled, click here.
  • For irbesartan-containing products currently recalled, click here.
  • For losartan-containing products currently recalled, click here. ”

 

ETA:

Recall expanded Feb 28th, 2019 https://www.fda.gov/Safety/Recalls/ucm632395.htm?utm_campaign=Camber Pharmaceuticals%2C Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets

“Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

NMBA is a potential human carcinogen. To date, Camber has not received any reports of adverse events related to this recall.

Losartan Potassium, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, 1000ct bottles. The identifying NDC #s associated with Camber’s product as are follows: Losartan 25 mg 31722-700-9031722-700-0531722-700-10; Losartan 50 mg 31722-701-3031722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-3031722-702-90, and 31722-702-10.

The affected Losartan includes 87 lot numbers which are listed below” 

ETA:

Recall expanded March 1st, 2019 https://www.fda.gov/Safety/Recalls/ucm632442.htm

“AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.” https://www.fda.gov/Safety/Recalls/ucm632442.htm

ETA:

Recall expanded March 1st 

“Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The products subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.” https://www.fda.gov/Safety/Recalls/ucm632509.htm

ETA:

Recall March 7th https://www.fda.gov/Safety/Recalls/ucm632924.htm

“American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Product Description AHP Lot No. Expiration Date
Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters
Carton NDC#: 60687-139-01
(Individual Dose NDC: 60687-139-11)
179791 3/31/2020

American Health Packaging is notifying its distributors by recall letter sent March 6th, 2019 and to immediately discontinue distribution of the specific lots being recalled and to notify their sub- accounts. American Health Packaging is arranging for return of all recalled products to GENCO Pharmaceutical Services. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact any patients who may have received the recall lots and have them call (877) 475-5864 to receive a return packet. Consumers should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.”

ETA:

Expanded 15th March 

“The identifying NDC number associated with Legacy’s product is as follows:

Losartan Potassium, USP, 50mg  NDC 68645-494-54

The affected Losartan Potassium includes 3 repackaged lots numbers which are listed below:

LEGACY NDC# Name and Strength Count Legacy Lot # Expiry
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180190 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180191 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 181597 02/2021

The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.” 

https://www.fda.gov/Safety/Recalls/ucm633671.htm

ETA:

Recall issued March 25th

From FDA https://www.fda.gov/Safety/Recalls/ucm633664.htm

“Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The identifying NDC numbers associated with Legacy’s product are as follows:

               Losartan Potassium, USP, 25mg                   NDC 68645-577-54 
               Losartan Potassium, USP, 50mg                   NDC 68645-578-54 
               Losartan Potassium, USP, 100mg                 NDC 68645-579-54

The affected Losartan Potassium includes 40 repackaged lots numbers which are listed below” https://www.fda.gov/Safety/Recalls/ucm633664.htm

“If you have any medical questions regarding this recall, please contact Camber Pharmaceuticals, Inc. at 1-866-495-1995 (8:00 am – 4:30 pm Eastern Time).

Consumers with questions regarding this recall can contact your dispensing pharmacy during normal business hours. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”

ETA:

Recall issued April 18th

From FDA https://www.fda.gov/Safety/Recalls/ucm636296.htm (affected lots detailed info in link)

“Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP”

Edited by Arcadia
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We received a letter from dh's pharmacy provider about one of the Torrent meds.  The local pharmacist who is usually very good, was not thrilled about having to swap out dh's meds.  They do not keep records of lot numbers, so there was no way to know what lot number was in the bottle, other than that it was a manufacturer who is subject to recalls.  I was surprised at the reluctance. 

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  • 1 month later...

Recall expanded Feb 28th, 2019 https://www.fda.gov/Safety/Recalls/ucm632395.htm?utm_campaign=Camber Pharmaceuticals%2C Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets

“Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

NMBA is a potential human carcinogen. To date, Camber has not received any reports of adverse events related to this recall.

Losartan Potassium, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, 1000ct bottles. The identifying NDC #s associated with Camber’s product as are follows: Losartan 25 mg 31722-700-9031722-700-0531722-700-10; Losartan 50 mg 31722-701-3031722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-3031722-702-90, and 31722-702-10.

The affected Losartan includes 87 lot numbers which are listed below” 

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Recall expanded March 1st, 2019 https://www.fda.gov/Safety/Recalls/ucm632442.htm

“AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.” https://www.fda.gov/Safety/Recalls/ucm632442.htm

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Recall expanded March 1st https://www.fda.gov/Safety/Recalls/ucm632509.htm

“Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The products subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.” https://www.fda.gov/Safety/Recalls/ucm632509.htm

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I checked and mine are fine. 

I do wish that pharmacists would have a list and contact consumers who have the ones that are recalled. Checking mine every time there's yet another recall, and there are quite a lot these days, is a bit of a pain. I know that it's not possible, but I guess I can wish. 

Thank you again, so much, for keeping us updated. 

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3 hours ago, Negin said:

I do wish that pharmacists would have a list and contact consumers who have the ones that are recalled.

 

When my mom’s rheumatoid arthritis drug was recalled, her rheumatologist was the one who informed her. I think that’s easier to implement than the pharmacist calling as people change pharmacies more frequently.

Edited by Arcadia
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6 hours ago, Arcadia said:

 

When my mom’s rheumatoid arthritis drug was recalled, her rheumatologist was the one who informed her. I think that’s easier to implement than the pharmacist calling as people change pharmacies more frequently.

That would be ideal also. I wish that some health care professional would notify consumers. 

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43 minutes ago, TCB said:

I tried to see but wasn't sure if this is just irbesartan made by some manufacturers, or irbesartan itself?

 

Irbesartan is not being recalled. Certain lots/batches of Irbesartan are being recalled due to the presence of N-nitrosodiethylamine (NDEA) contamination above FDA limits.

Edited by Arcadia
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4 hours ago, Arcadia said:

 

Irbesartan is not being recalled. Certain lots/batches of Irbesartan are being recalled due to the presence of N-nitrosodiethylamine (NDEA) contamination above FDA limits.

Thanks!

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Recall March 7th https://www.fda.gov/Safety/Recalls/ucm632924.htm

“American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Product Description AHP Lot No. Expiration Date
Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters
Carton NDC#: 60687-139-01
(Individual Dose NDC: 60687-139-11)
179791 3/31/2020

American Health Packaging is notifying its distributors by recall letter sent March 6th, 2019 and to immediately discontinue distribution of the specific lots being recalled and to notify their sub- accounts. American Health Packaging is arranging for return of all recalled products to GENCO Pharmaceutical Services. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact any patients who may have received the recall lots and have them call (877) 475-5864 to receive a return packet. Consumers should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.”

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  • 2 weeks later...

Recall March 15th https://www.fda.gov/Safety/Recalls/ucm633671.htm

“The affected Losartan Potassium includes 3 repackaged lots numbers which are listed below:

LEGACY NDC# Name and Strength Count Legacy Lot # Expiry
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180190 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180191 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 181597 02/2021

The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning recalled products are provided in the recall letter.

Consumers with questions regarding this recall can contact Inmar at 1-877-538-8443, Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”

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  • 2 weeks later...

Recall issued March 25th

From FDA https://www.fda.gov/Safety/Recalls/ucm633664.htm

“Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The identifying NDC numbers associated with Legacy’s product are as follows:

               Losartan Potassium, USP, 25mg                   NDC 68645-577-54 
               Losartan Potassium, USP, 50mg                   NDC 68645-578-54 
               Losartan Potassium, USP, 100mg                 NDC 68645-579-54

The affected Losartan Potassium includes 40 repackaged lots numbers which are listed below” https://www.fda.gov/Safety/Recalls/ucm633664.htm

“If you have any medical questions regarding this recall, please contact Camber Pharmaceuticals, Inc. at 1-866-495-1995 (8:00 am – 4:30 pm Eastern Time).

Consumers with questions regarding this recall can contact your dispensing pharmacy during normal business hours. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”

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  • 3 weeks later...

Recall issued April 18th

From FDA https://www.fda.gov/Safety/Recalls/ucm636296.htm (affected lots detailed info in link)

“Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP”

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Recall issued 24th April 2019 https://www.fda.gov/Safety/Recalls/ucm636624.htm

“Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot.

...

The identifying NDC number associated with Legacy’s product is as follows:

Losartan Potassium, USP, 50mg NDC 68645-494-54

The affected Losartan Potassium includes 4 repackaged lots numbers (3 initial repackaged lot and 1 expanded repackaged lot) which are listed below:

LEGACY NDC# Name and Strength Count Legacy Lot # Expiry
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180190 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180191 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 181597 02/2021
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 181598 02/2021

The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning recalled products are provided in the recall letter.

Consumers with questions regarding this recall can contact Inmar at 1-877-538-8443, Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have that may be related to taking or using this drug product.”

 

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FDA Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan (Content current as of: 04/29/2019) https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and

Recalled issued 3rd June 2019 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vivimed-life-sciences-pvt-ltd-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-50-mg-and

“The identifying NDC #s associated with Heritage distributed product are as follows:
Losartan Tablets 25 mg: 90- count: NDC 23155-644-09External Link Disclaimer, Losartan Tablets 50 mg: 90- count: NDC 23155-645-09External Link Disclaimer; 1000-count: NDC 23155-645-10External Link Disclaimer, Losartan Tablets 100 mg: 90-count- NDC 23155-646-09External Link Disclaimer   1000-count: NDC 23155-646-10External Link Disclaimer.

The affected Losartan Potassium tablets, includes the 19 lot numbers which are listed below:

Product Name Lot Number Pack Expiry Date Distributed by 
Losartan Potassium Tablets USP, 25 mg CLO17006A 90’s Nov 2019 HERITAGE  
Losartan Potassium Tablets USP, 50 mg CLO17007A 1000's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 50 mg CLO17008A 1000's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 50 mg CLO17009A 1000's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 50 mg CLO17009B 90's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 50 mg CLO17010A 90's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17012A 90's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17013A 90's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17014A 1000's Dec 2019 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17015A 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17016A 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17017A 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18001A 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18002A 90's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18002B 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18020A 90's Apr 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18021A 90's Apr 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18022A 90's Apr 2020 HERITAGE  
Losartan Potassium Tablets USP, 50 mg CLO18023A 90's Apr 2020 HERITAGE  

Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Inmar is notifying distributors and other customers by recall notification and arranging for return of recalled product of Losartan Potassium Tablets from the above lots.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product. Pharmacies and healthcare facilities that have the product being recalled from above listed lots should stop using and dispensing the product immediately. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers with questions regarding this recall can contact Vivimed C/o Inmar at  1-877-861-3811External Link Disclaimer Monday – Friday, 9am – 5pm EST.”

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  • 3 months later...

Recall expanded again https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium-0#recall-announcement

The product/lots included in the expanded recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium / Hydrochlorothiazide Tablet Lots

NDC Product Name, Strength and Package Count Batch Number Expiration Date
13668-409-10External Link Disclaimer Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E009 12/31/2020
13668-115-90External Link Disclaimer Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E009 12/31/2020
13668-115-10External Link Disclaimer Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E018 02/28/2021
13668-116-90External Link Disclaimer Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D051 11/30/2020
13668-118-90External Link Disclaimer Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. 4P04D007 07/31/2020

Losartan Potassium tablets, USP and Losartan Potassium/Hydrochlorothiazide tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”

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