Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Reported: February 2, 2022 Initiated: December 27, 2021 #D-0392-2022
Product Description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles 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
- 23,8416/100 count bottles
- Distribution
- Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
- Location
- Cranford, NJ
Frequently Asked Questions
What product was recalled? ▼
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01. Recalled by VIONA PHARMACEUTICALS INC. Units affected: 23,8416/100 count 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 February 2, 2022. Severity: Moderate. Recall number: D-0392-2022.
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