September 2020 FDA Recall Drug by Legacy Pharmaceutical Packaging Llc
D-1626-2020 - Presence of Foreign Tablets/Capsules

This Class III drug recall was voluntarily initiated by Legacy Pharmaceutical Packaging Llc on September 24, 2020 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in Walmart distribution centers in GA and AR and the recall is currently terminated.

Recall Number: D-1626-2020

Reason for Recall
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Initiated
09-24-2020
Reported
10-07-2020
Quantity
111,948 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86471
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Legacy Pharmaceutical Packaging LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Walmart distribution centers in GA and AR
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2022
Product Description About Product Description
Full technical description of the product.
Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59

Batch or Lot Expiration Information

Lot# : 201626, Exp. Date 08/2022