Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
Reported: June 30, 2021 Initiated: June 1, 2021 #D-0640-2021
Product Description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Details
- Recalling Firm
- VIONA PHARMACEUTICALS INC
- Units Affected
- 21240 bottles
- Distribution
- Nationwide in the US
- Location
- Cranford, NJ
Frequently Asked Questions
What product was recalled? ▼
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01. Recalled by VIONA PHARMACEUTICALS INC. Units affected: 21240 bottles.
Why was this product recalled? ▼
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 30, 2021. Severity: Moderate. Recall number: D-0640-2021.
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