Recall Enforment Report D-1289-2019
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Heritage Pharmaceuticals, Inc., originally initiated on 05-03-2019 for the product 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 The product was recalled due to 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. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1289-2019 | 05-03-2019 | 05-29-2019 | Class II | 34403 bottles | 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 | 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 | Terminated |
| D-1290-2019 | 05-03-2019 | 05-29-2019 | Class II | 3697 bottles | Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only 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 23155-646-10 | 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 | Terminated |
| D-1288-2019 | 05-03-2019 | 05-29-2019 | Class II | 25220 bottles | Losartan Potassium Tablets USP 100 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 23155-646-09 | 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 | Terminated |
| D-1291-2019 | 05-03-2019 | 05-29-2019 | Class II | 15541 bottles | Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only 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 23155-644-09 | 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 | Terminated |
| D-1287-2019 | 05-03-2019 | 05-29-2019 | Class II | 3012 bottles | Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only 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 23155-645-10 | 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 | Terminated |
