February 2023 FDA Recall Drug by Teva Pharmaceuticals Usa Inc
D-0441-2023 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa Inc on February 22, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in CA and the recall is currently terminated.

Recall Number: D-0441-2023

Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Initiated
02-22-2023
Reported
03-15-2023
Quantity
12,044 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91744
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2023
Product Description About Product Description
Full technical description of the product.
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60

Batch or Lot Expiration Information

Lot# : 1410946A; Exp. 06/2023