December 2018 FDA Recall Clopidogrel Bisulfate by Dr. Reddy's Laboratories, Inc.
D-0294-2019 - Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on December 10, 2018 for the product Clopidogrel Bisulfate. The FDA reported the reason for recall as failed dissolution specification -two additional lots being recalled due to out-of-specification results observed for dissolution at 18th month stability testing.. The product was distributed in Product was distributed to 4 major distributors who distributed the product throughout the United States. and the recall is currently terminated.
Recall Number: D-0294-2019
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
12-10-2018
12-19-2018
4,404 (30 count blister packs)
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 4 major distributors who distributed the product throughout the United States.
06-25-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31
Batch or Lot Expiration Information
Lot# : T700423, Exp 08/2019; T800310, Exp 03/2020
