D-0696-2017 Class II Terminated
FDA drug recall D-0696-2017 was initiated by Akorn Inc on March 13, 2017 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated July 9, 2019). Affected quantity: 55,968 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 10, 2017
- Initiation Date
- March 13, 2017
- Termination Date
- July 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55,968 bottles
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide
Code Information
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