Drug recall
Proin ER" (phenylpropanolamine hydrochloride extended-release tablets) 145 mg
FDA recall event 93694 · Class III · Pegasus Laboratories, Inc.
Key facts
| Event ID | 93694 |
|---|---|
| Recall numbers | V-0031-2024 |
| Recalling firm | Pegasus Laboratories, Inc. |
| Product type | Veterinary |
| Products | Proin ER" (phenylpropanolamine hydrochloride extended-release tablets) 145 mg |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Due to multiple complaints (broken tablets) and a 3-month CRT stability failure for hardness. |
| Initiation date | Dec 29, 2023 |
| Report date | Jan 17, 2024 |
| Termination date | Mar 20, 2025 |
| City | Pensacola |
| State | FL |
| Country | United States |
| FEI number | 1038896 |
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: