Recalls / Class II
Class IID-0997-2015
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
- Affected lot / code info
- Lot # 624271, Exp. Date 10/2015
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
- 8,400 unit dose cups (20 mL 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-0997-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.