December 2021 FDA Recall Drug by Remedyrepack Inc.
D-0366-2022 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on December 30, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to one direct account in PA. and the recall is currently terminated.

Recall Number: D-0366-2022

Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Initiated
12-30-2021
Reported
01-19-2022
Quantity
56 Blister Cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89331
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 direct account in PA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2022
Product Description About Product Description
Full technical description of the product.
Metformin 750 mg Extended Release NDC # 70518-2920-00

Batch or Lot Expiration Information

Lot# J0511265-021121, exp. date 02/28/2022 J0499451-122220, exp. date 01/31/2022 J0496563-120820, exp. date 12/31/2021 J0495111-120120, exp. date 12/31/2021