June 2020 FDA Recall Drug by The Harvard Drug Group
D-1360-2020 - CGMP Deviation

This Class II drug recall was voluntarily initiated by The Harvard Drug Group on June 12, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1360-2020

Reason for Recall
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Initiated
06-12-2020
Reported
07-08-2020
Quantity
1,906 Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85861
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.
The Harvard Drug Group
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2022
Product Description About Product Description
Full technical description of the product.
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61

Batch or Lot Expiration Information

Lot# Lot T-02134, exp 09/2020