Recalls / Class II
Class IID-0294-2019
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
- Brand name
- Clopidogrel Bisulfate
- Generic name
- Clopidogrel Bisulfate
- Active ingredient
- Clopidogrel Bisulfate
- Route
- Oral
- NDC
- 55111-671
- FDA application
- ANDA091023
- Affected lot / code info
- Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
Why it was recalled
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 4,404 (30 count blister packs)
- Distribution pattern
- Product was distributed to 4 major distributors who distributed the product throughout the United States.
Timeline
- Recall initiated
- 2018-12-10
- FDA classified
- 2018-12-11
- Posted by FDA
- 2018-12-19
- Terminated
- 2020-06-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0294-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.