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.
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
Lot numbers, UPCs & expiration codes
Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
Where it was sold
Product was distributed to 4 major distributors who distributed the product throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0294-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 10, 2018
- FDA report date
- Dec 19, 2018
- Quantity
- 4,404 (30 count blister packs)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0294-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81748
- Address
- 107 College Rd E
- Code information
- Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
- Postal code
- 08540-6623
- Report date
- Dec 19, 2018
- Product type
- Drugs
- Recall number
- D-0294-2019
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 4,404 (30 count blister packs)
- Termination date
- Jun 25, 2020
- Reason for recall
- Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 4 major distributors who distributed the product throughout the United States.
- Recall initiation date
- Dec 10, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 11, 2018