FDA Drug recall D-0553-2022
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc.,…
- FDA Drug
- Class II
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc.,… by Ultratab Laboratories, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0553-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ultratab Laboratories |
| Distribution | n/a |
Product
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
Reason
CGMP Deviations
Identifiers
| code_info | Product Codes: M800L Bulk Lots: 18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0553-2022%22
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