Drug recall
PROIN ER, (Phenylpropanolamine hydrochloride extended-release tablets), 145 mg, net content 90 tablets…
FDA recall event 97578 · Class II · Pegasus Laboratories, Inc.
Key facts
| Event ID | 97578 |
|---|---|
| Recall numbers | V-0112-2025 |
| Recalling firm | Pegasus Laboratories, Inc. |
| Product type | Veterinary |
| Products | PROIN ER, (Phenylpropanolamine hydrochloride extended-release tablets), 145 mg, net content 90 tablets, MANUFACTURED BY: Pegasus Laboratories, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | An out of specification result was confirmed after data review in dissolution testing for Proin ER 145mg lot 25079A1 (ST10431 - 3 mo. @ CRT) @ 16 hours. |
| Initiation date | Sep 12, 2025 |
| Report date | Sep 24, 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: