Why it was recalled
Failed Dissolution Specification: Out-of-Specification results were 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 #: T600530, Exp 11/18
Where it was sold
U.S.A.nationwide
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-0283-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 7, 2018
- FDA report date
- Nov 28, 2018
- Quantity
- 4,212 (30-count blister pack)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0283-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81530
- Address
- 107 College Rd E
- Code information
- Lot #: T600530, Exp 11/18
- Postal code
- 08540-6623
- Report date
- Nov 28, 2018
- Product type
- Drugs
- Recall number
- D-0283-2019
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 4,212 (30-count blister pack)
- Termination date
- May 19, 2020
- Reason for recall
- Failed Dissolution Specification: Out-of-Specification results were 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
- U.S.A.nationwide
- Recall initiation date
- Nov 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 27, 2018