Recalls / Class II
Class IID-0696-2017
Product
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
- Affected lot / code info
- Lot# 348913, Exp.01/18; Lot# 349552, Exp.03/18; Lot# 349681, Exp. 03/18; Lot# 349683, Exp. 03/18; Lot# 349685, Exp. 03/18; Lot# 349687, Exp. 03/18; Lot# 349689, Exp. 03/18; Lot# 350636, Exp.03/18
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 55,968 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-03-13
- FDA classified
- 2017-05-04
- Posted by FDA
- 2017-05-10
- Terminated
- 2019-07-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0696-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.