Why it was recalled
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Product description
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01
Lot numbers, UPCs & expiration codes
Lot # C206578 Exp. 05/2014 Lot # C207415 Exp. 06/2014
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-1381-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 23, 2014
- FDA report date
- Jun 18, 2014
- Quantity
- 13560 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1381-2014, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68513
- Address
- 107 College Rd E
- Code information
- Lot # C206578 Exp. 05/2014 Lot # C207415 Exp. 06/2014
- Postal code
- 08540-6623
- Report date
- Jun 18, 2014
- Product type
- Drugs
- Recall number
- D-1381-2014
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 13560 bottles
- Termination date
- May 1, 2015
- Reason for recall
- Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01
- Distribution pattern
- Nationwide
- Recall initiation date
- May 23, 2014
- Initial firm notification
- Letter
- Center classification date
- Jun 12, 2014