Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reported: June 24, 2020 Initiated: June 4, 2020 #D-1304-2020
Product Description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 88,545 bottles
- Distribution
- Nationwide.
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478. Recalled by AVKARE Inc.. Units affected: 88,545 bottles.
Why was this product recalled? ▼
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 24, 2020. Severity: Moderate. Recall number: D-1304-2020.
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