FDA Drug recall D-1450-2014
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimeth…
- FDA Drug
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimeth… by Shamrock Medical Solutions Group, citing labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1450-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-27 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Shamrock Medical Solutions Group |
| Distribution | CO, MA, OH, TX, WY |
Product
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01
Reason
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Identifiers
| ndc | 53746-271-50 |
|---|---|
| ndc | 53746-271-01 |
| ndc | 53746-271-05 |
| ndc | 53746-271-10 |
| ndc | 53746-272-11 |
| ndc | 53746-272-24 |
| ndc | 53746-272-01 |
| ndc | 53746-272-02 |
| ndc | 53746-272-05 |
| code_info | Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01 |
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-1450-2014%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.