Recalls / Class II
Class IID-0995-2015
Product
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
- Affected lot / code info
- Lot # 623940, Exp. 10/2015; Lot # 624487, Exp. 11/2015; Lot # 624741, Exp. 11/2015; Lot # 625296, Exp. 1/2016
Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W. Field Court, Suite 300, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 27,648 bottles (16 fl. oz. each)
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-03-17
- FDA classified
- 2015-05-08
- Posted by FDA
- 2015-05-20
- Terminated
- 2017-12-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0995-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.