Class II
Terminated
Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-09
- Company
- Heritage Pharmaceuticals Inc
- Recall Initiated
- May 3, 2019
- Posted
- May 29, 2019
- Recall Number
- D-1289-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 34403 bottles
- Firm Location
- East Brunswick, NJ, United States
Reason for Recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Distribution
Nationwide
Lot / Code Info
Lot CLO17009B exp 11/2019 Lot CLO17010A exp 11/2019 Lot CLO18023A exp 04/2020
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