Clopidogrel Bisulfate Tablet, Film Coated
FDA Recall NDC 55111-671
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Clopidogrel Bisulfate (NDC 55111-671). A significant event, classified as Class II, was initiated on Dec 10, 2018 by Dr.reddy's Laboratories Limited. The reported reason for this action was: "Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2018 Class II Recall: Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Recall Number
Class II Terminated
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Dec 10, 2018
Dec 19, 2018
4,404 (30 count blister packs)
Recall Profile & Regulatory Data
Event ID
81748
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 4 major distributors who distributed the product throughout the United States.
Termination Date
Jun 25, 2020
Product Description
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
Affected Packages Involved in this Recall
55111-671-30Product
55111-671-90Product
55111-671-01Product
55111-671-05Product
55111-671-48Product
55111-671-79Product
55111-671-81Product
55111-671-06Product
55111-671-31Product
55111-671-78Product
Class II Terminated
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Nov 07, 2018
Nov 28, 2018
4,212 (30-count blister pack)
Recall Profile & Regulatory Data
Event ID
81530
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A.nationwide
Termination Date
May 19, 2020
Product Description
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# : T600530, Exp 11/18
Affected Packages Involved in this Recall
55111-671-30Product
55111-671-90Product
55111-671-01Product
55111-671-05Product
55111-671-48Product
55111-671-79Product
55111-671-81Product
55111-671-06Product
55111-671-31Product
55111-671-78Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
