October 2020 FDA Recall Drug by Remedyrepack Inc.
D-0050-2021 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on October 11, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to one customer in PA. and the recall is currently terminated.

Recall Number: D-0050-2021

Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Initiated
10-11-2020
Reported
11-04-2020
Quantity
79/30 count blister cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86624
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.
RemedyRepack 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.
Product was distributed to one customer in PA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-24-2021
Product Description About Product Description
Full technical description of the product.
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00

Batch or Lot Expiration Information

Lot# Lot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021