December 2019 FDA Recall Drug by Remedyrepack Inc. (D-0798-2020 - CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.)

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on December 11, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviation; received notice from supplier of potential -nitrosodimethylamine (ndma) amounts above established levels.. The product was distributed in Product was distributed to two facilities in CA and NY. and the recall is currently terminated.

Recall Number: D-0798-2020

Reason for Recall
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Initiated
12-11-2019
Reported
01-29-2020
Quantity
4,486 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84696
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 two facilities in CA and NY.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

Batch or Lot Expiration Information

Lot# : J0376034-052319, exp. date 05/2020
Lot# : J0406133-093019, exp. date 10/2020
Lot# : J038005-082719, exp. date 08/2020
Lot# : J0390280-072519, exp. date 07/2020
Lot# : J0390277-072519, exp. date 07/2020
Lot# : J0349352-012519, exp. date 01/2020