Multi event Drug Recall Enforcement Report Class II voluntary initiated by Nostrum Laboratories Inc, originally initiated on 10-23-2020 for the product Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01 The product was recalled due to cgmp deviations: detection of n-nitrosodimethylamine (ndma) impurity above the acceptable intake level. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0068-2021 | 10-23-2020 | 11-11-2020 | Class II | 20,872 bottles | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Ongoing |
| D-0067-2021 | 10-23-2020 | 11-11-2020 | Class II | 12,967 bottles | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 29033-055 | Metformin Hydrochloride | Metformin Hydrochloride | Tablet, Extended Release | Oral | Nostrum Laboratories Inc. | Human Prescription Drug |
| 29033-056 | Metformin Hydrochloride | Metformin Hydrochloride | Tablet, Extended Release | Oral | Nostrum Laboratories Inc. | Human Prescription Drug |
