Why it was recalled
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
Product description
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01
Lot numbers, UPCs & expiration codes
Batch # C706254, 08/2019
Where it was sold
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-0727-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 23, 2018
- FDA report date
- May 16, 2018
- Quantity
- 8160 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0727-2018, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79980
- Address
- 107 College Rd E
- Code information
- Batch # C706254, 08/2019
- Postal code
- 08540-6623
- Report date
- May 16, 2018
- Product type
- Drugs
- Recall number
- D-0727-2018
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 8160 bottles
- Termination date
- Dec 14, 2020
- Reason for recall
- Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 23, 2018
- Initial firm notification
- Letter
- Center classification date
- May 9, 2018