Recall Enforment Report D-0441-2023

Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA Inc, originally initiated on 02-22-2023 for 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 The product was recalled due to cgmp deviations: detection of n-nitrosodimethylamine (ndma) levels in excess of the acceptable daily intake limit.. The product was distributed in Ca and the recall is currently ongoing.

Field Name	Field Value
Event ID	91744 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0441-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	CA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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
Reason For Recall	CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	12,044 Bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-15-2023
Recall Initiation Date	02-22-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Teva Pharmaceuticals USA Inc
Code Info	Lot #: 1410946A; Exp. 06/2023 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Ongoing