Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Reported: November 4, 2020 Initiated: October 11, 2020 #D-0050-2021
Product Description
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 79/30 count blister cards
- Distribution
- Product was distributed to one customer in PA.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00. Recalled by RemedyRepack Inc.. Units affected: 79/30 count blister cards.
Why was this product recalled? ▼
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 4, 2020. Severity: Moderate. Recall number: D-0050-2021.
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