FDA-Drug2022-06-08Class II
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
Strides Pharma Inc.
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Sold states
Nationwide
Affected count
381456 bottles
Manufactured in
2 Tower Center Blvd Ste 1102, N/A, East Brunswick, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0973-2022Don't want to check this manually?
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