Skip to main content

Recall Expanded For 5 Lots Of Losartan Drugs

Recall Expanded For 5 Lots Of Losartan Drugs

Recall Expanded For 5 Lots Of Losartan Drugs

Introduction

On September 19, the U.S. Food & Drug Administration (FDA) expanded recall on three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets. The recall announced on Monday included losartan drugs sold by Torrent Pharmaceuticals.

The affected batches include:

13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count. Batch number: 4DU2E009. Expiration date: 12/31/2020.

13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count. Batch number: 4DU3E009. Expiration date: 12/31/2020.

13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count. Batch number: 4DU3E018. Expiration date: 02/28/2021.

13668-116-90 Losartan Potassium/Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count. Batch number: BEF7D051. Expiration date: 11/30/2020.

13668-118-90 Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. Batch number: 4P04D007. Expiration date: 07/31/2020.

The recalled drugs belong to a class called angiotensin II receptor blockers (ARBs) and are used to treat heart failure and high blood pressure. The recalled lots contained nitroso-N-methyl-4-aminobutyric acid (NMBA) above the acceptable daily intake levels as determined by the FDA. Drugmakers around the world have recalled their losartan, valsartan, and irbesartan products due to the presence of NMBA and other cancer-causing chemicals in active pharmaceutical ingredients sourced from suppliers in China and India.

More than 130 valsartan lawsuits in connection with the recalls are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J. Lawsuits associated with the irbesartan or losartan recall are currently not included in the federal litigation. However, a request to expand the proceeding to include these claims were made by a group of plaintiffs.

Comments

Restricted HTML

  • Allowed HTML tags: <a href hreflang> <em> <strong> <cite> <blockquote cite> <code> <ul type> <ol start type> <li> <dl> <dt> <dd> <h2 id> <h3 id> <h4 id> <h5 id> <h6 id>
  • Lines and paragraphs break automatically.
  • Web page addresses and email addresses turn into links automatically.

Latest News

NC to Get $150M to Boost Opioid Treatment, Recovery

Categories: Opioids

North Carolina will receive an additional $150 million from Purdue Pharma and the Sackler family as part of a national $7.4 billion settlement related to the opioid

SRI Gets FDA OK for High-Dose Naloxone Trial

Categories: Opioids

SRI has received authorization from the U.S. Food and Drug Administration (FDA) to begin Phase 1 clinical trials of a new, high-dose injectable naloxone formulation.

The approval was granted under an Investigational New Drug (IND)…

Spokane County to Get $5M in New Opioid Settlement

Categories: Opioids

Jurisdictions within Spokane County are set to receive nearly $4.7 million as part of a sweeping $7.4 billion nationwide settlement with Purdue Pharma and its owners, the Sackler family.

The agreement addresses the company’s role in fueling…

✍️ FREE—3000 Pages Medical Record Review Trial!                
No Contract. No Risk—Fully Customized, Free!

Only 10 Firms Accepted—Offer Ends June 30!