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
Reported: June 8, 2022 Initiated: May 18, 2022 #D-0973-2022
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
Details
- Recalling Firm
- Strides Pharma Inc.
- Units Affected
- 381456 bottles
- Distribution
- Nationwide
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Strides Pharma Inc.. Units affected: 381456 bottles.
Why was this product recalled? ▼
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 8, 2022. Severity: Moderate. Recall number: D-0973-2022.
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