FDA Drug recall D-0538-2022
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highl…
- FDA Drug
- Class II
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highl… by Ultratab Laboratories, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0538-2022 |
| 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
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
Reason
CGMP Deviations
Identifiers
| code_info | Product Codes: L242SRC Bulk Lot: 18K086, 18L009, 18L050, 18L083, 18M025, 18M073, 18M098, 19A010, 19A084, 19A105, 19A107…Product Codes: L242SRC Bulk Lot: 18K086, 18L009, 18L050, 18L083, 18M025, 18M073, 18M098, 19A010, 19A084, 19A105, 19A107; Product Code: L242L Bulk Lot: 19H014; Product Code: L242PA Bulk Lot: 18F072, 18L119, 19A067, 19G043; Product Code: L242N Bulk Lot: 19H040 |
|---|
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-0538-2022%22
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