Drug recall
Sleepinal Softgels, (Diphenhydramine Hydrochloride), 50mg, 16 count blisterpacks, Maximum Strength, night-time…
FDA recall event 36768 · Class III · Blairex Laboratories, Inc
Key facts
| Event ID | 36768 |
|---|---|
| Recall numbers | D-783-2007 |
| Recalling firm | Blairex Laboratories, Inc |
| Product type | Drugs |
| Products | Sleepinal Softgels, (Diphenhydramine Hydrochloride), 50mg, 16 count blisterpacks, Maximum Strength, night-time sleep-aid, Manufactured for Blairex Laboratories, Inc., Columbus, IN |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Dissolution Requirement; 21 month test station |
| Initiation date | Oct 30, 2006 |
| City | Columbus |
| Country | United States |
| FEI number | 1825549 |
At a glance
- 1–9 Products in this recall
- 1–9 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