Home / Recalls / Strides Pharma Inc. / D-0974-2022

D-0974-2022 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
96966 bottles

Product 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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

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

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-0294-2025 Class II — Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distrib (March 5, 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-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-0973-2022 Class II — Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life S (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)