Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Product description
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Lot numbers, UPCs & expiration codes
Lot # 623940, Exp. 10/2015; Lot # 624487, Exp. 11/2015; Lot # 624741, Exp. 11/2015; Lot # 625296, Exp. 1/2016
Where it was sold
Nationwide and Puerto Rico
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-0995-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 17, 2015
- FDA report date
- May 20, 2015
- Quantity
- 27,648 bottles (16 fl. oz. each)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0995-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70743
- Address
- 1925 W. Field Court, Suite 300
- Code information
- Lot # 623940, Exp. 10/2015; Lot # 624487, Exp. 11/2015; Lot # 624741, Exp. 11/2015; Lot # 625296, Exp. 1/2016
- Postal code
- 60045
- Report date
- May 20, 2015
- Product type
- Drugs
- Recall number
- D-0995-2015
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 27,648 bottles (16 fl. oz. each)
- Termination date
- Dec 27, 2017
- Reason for recall
- Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 17, 2015
- Initial firm notification
- Letter
- Center classification date
- May 8, 2015