Drug recall
PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in…
FDA recall event 89214 · Class II · ULTRAtab Laboratories, Inc.
Key facts
| Event ID | 89214 |
|---|---|
| Recall numbers | D-0327-2022 |
| Recalling firm | ULTRAtab Laboratories, Inc. |
| Product type | Drugs |
| Products | PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC#… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: failed stability results, inadequate laboratory investigations, |
| Initiation date | Nov 29, 2021 |
| Report date | Jan 12, 2022 |
| Termination date | Feb 24, 2023 |
| City | Highland |
| State | NY |
| Country | United States |
| FEI number | 3003068822 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: