June 2020 FDA Recall Drug by Remedyrepack Inc.
D-1387-2020 - FAILED DISSOLUTION SPECIFICATION

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on June 29, 2020 for the product Drug. The FDA reported the reason for recall as failed dissolution specification. The product was distributed in Product was distributed to MN. and the recall is currently terminated.

Recall Number: D-1387-2020

Reason for Recall
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Initiated
06-29-2020
Reported
07-22-2020
Quantity
498 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86006
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 MN.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-14-2020
Product Description About Product Description
Full technical description of the product.
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.

Batch or Lot Expiration Information

Lot# : B0796217-020920, Exp. Date: 02/28/2021