Why it was recalled
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Product description
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Lot numbers, UPCs & expiration codes
Lot C203090 Exp.03/14
Where it was sold
Nationwide. No foreign consignees.
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-059-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2012
- FDA report date
- Nov 28, 2012
- Quantity
- 1512 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-059-2013, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63524
- Address
- 200 Somerset Corporate Blvd Fl 7th
- Code information
- Lot C203090 Exp.03/14
- Postal code
- 08807-2862
- Report date
- Nov 28, 2012
- Product type
- Drugs
- Recall number
- D-059-2013
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 1512 bottles
- Termination date
- Jul 10, 2013
- Reason for recall
- Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
- Distribution pattern
- Nationwide. No foreign consignees.
- Recall initiation date
- Sep 27, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2012