FDA Drug recall D-0997-2015
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx on…
- FDA Drug
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx on… by Akorn, citing failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0997-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-17 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Akorn |
| Distribution | US |
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
Reason
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Identifiers
| code_info | Lot # 624271, Exp. Date 10/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0997-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.