Strides Pharma Inc.: Drug Recall

Recall #D-0973-2022 · 05/18/2022

Class II: Risk

Recall Details

Recall Number
D-0973-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Strides Pharma Inc.
Status
Terminated
Date Initiated
05/18/2022
Location
East Brunswick, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
381456 bottles

Reason for Recall

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

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

Distribution Pattern

Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.