FDA Drug recall D-0050-2021
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2…
- FDA Drug
- Class II
- terminated
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2… by Remedyrepack, citing CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0050-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-11 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Remedyrepack |
| Distribution | PA |
Product
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Identifiers
| code_info | Lot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/…Lot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0050-2021%22
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