Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Summary
The FDA issued a Class II for Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bot by VIONA PHARMACEUTICALS INC. Reason: CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit..
Details
Source
Drug Recall
External ID
D-0392-2022
Action Date
2022-02-02
Status
Terminated
Category
drug
Product Description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Lot/Code Info: M008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M013966 09/2022, M013967 09/2022, M100831 12/2022, M100832 12/2022, M100833 01/2023, M100834 01/2023, M101267 01/2023, M102718 01/2023, M102719 01/2023
Quantity Affected: 23,8416/100 count bottles
Reason for Recall
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-27
Company
Cranford, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 100 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
VIONA PHARMACEUTICALS INC has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (VIONA PHARMACEUTICALS INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does VIONA PHARMACEUTICALS INC have FDA actions?
VIONA PHARMACEUTICALS INC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0392-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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