Home / Recalls / Strides Pharma Inc. / D-0973-2022

D-0973-2022 Class II Terminated

Recalled by Strides Pharma Inc. — East Brunswick, NJ

Recall Details

Product Type
Drugs
Report Date
June 8, 2022
Initiation Date
May 18, 2022
Termination Date
October 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
381456 bottles

Product Description

Losartan Potassium Tablets, USP, 50 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 64380-934-05 1000 film coated tablets NDC 64380-934-08

Reason for Recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Distribution Pattern

Nationwide

Code Information

NDC 64380-934-05 Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 7901282A, 7901283A & 7901284A, Exp Date Nov-22; Lot 7901359A, 7901360A & 7901361A, Exp Date Dec-22; Lot 7901362A, 7901406A, 7901407A, 7901408A & 7901409A, Exp Date Jan-23. 64380-934-08 Lot 7901008A & 7901009A, Exp Date Jun-22; Lot 7901150A & 7901151A, Exp Date Sep-22; Lot 7901285B, 7901286B, 7901287A, 7901288A, 7901289A, 7901290A, 7901291A, 7901292A, 7901293A & 7901294A, Exp Date Nov-22.

Other recalls by Strides Pharma Inc.

  • D-0546-2025 Class II — Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Ph (July 9, 2025)
  • D-0293-2025 Class II — Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Dist (March 5, 2025)
  • D-0294-2025 Class II — Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distrib (March 5, 2025)
  • D-0260-2024 Class II — Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strid (December 29, 2023)
  • D-0895-2023 Class II — Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx (June 26, 2023)
  • D-1330-2022 Class II — Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strid (July 19, 2022)
  • D-0974-2022 Class II — Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life (May 18, 2022)
  • D-0972-2022 Class II — Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life S (May 18, 2022)
  • D-0006-2022 Class II — Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, R (September 27, 2021)
  • D-0180-2021 Class III — NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured (December 22, 2020)