Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08

Class I - Dangerous
💊 Drugs Recalled: May 18, 2022 Strides Pharma Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    64380-935-05 Lots 7901047B, 7901048B, 7901049B & 7901050B, Exp Date Jul-22; Lots 7901185A, 7901186A, 7901187A & 7901188A, Exp Date Oct-22; Lots 7901250A, 7901251A & 7901252A, Exp Date Nov-22. 64380-935-08 Lots 7900813B, 7900814B, 7900908A, 7900935A, 7900936A, 7900937A, 7900938A & 7900939B, Exp Date May-22; Lots 7901043A, 7901044A, 7901045A & 7901046A, Exp Date Jul-22; Lots 7901158B, 7901159B, 7901160B, 7901161A, 7901182A & 7901183A, Exp Date Sep-22; Lots 7901184A, 7901189A, 7901190A, 7901191A, 7901192A, 7901193A, 7901194A & 7901195A, Exp Date Oct-22; Lots 7901295B, 7901296B, 7901297B, 7901298B, 7901299B, 7901300B, 7901301B & 7901302B, Exp Date Nov-22; Lots 7901338A, 7901339A, 7901340A, 7901341A & 7901342A, Exp Date Dec-22; Lot 7901387A, Exp Date Jan-23
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Strides Pharma Inc.
Reason for Recall:
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08

Product Codes/Lot Numbers:

64380-935-05 Lots 7901047B, 7901048B, 7901049B & 7901050B, Exp Date Jul-22; Lots 7901185A, 7901186A, 7901187A & 7901188A, Exp Date Oct-22; Lots 7901250A, 7901251A & 7901252A, Exp Date Nov-22. 64380-935-08 Lots 7900813B, 7900814B, 7900908A, 7900935A, 7900936A, 7900937A, 7900938A & 7900939B, Exp Date May-22; Lots 7901043A, 7901044A, 7901045A & 7901046A, Exp Date Jul-22; Lots 7901158B, 7901159B, 7901160B, 7901161A, 7901182A & 7901183A, Exp Date Sep-22; Lots 7901184A, 7901189A, 7901190A, 7901191A, 7901192A, 7901193A, 7901194A & 7901195A, Exp Date Oct-22; Lots 7901295B, 7901296B, 7901297B, 7901298B, 7901299B, 7901300B, 7901301B & 7901302B, Exp Date Nov-22; Lots 7901338A, 7901339A, 7901340A, 7901341A & 7901342A, Exp Date Dec-22; Lot 7901387A, Exp Date Jan-23

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0974-2022

Related Recalls