Drug recall
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the…
FDA recall event 77007 · Class III · P & L Development, LLC
Key facts
| Event ID | 77007 |
|---|---|
| Recall numbers | D-0694-2017 |
| Recalling firm | P & L Development, LLC |
| Product type | Drugs |
| Products | Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point. |
| Initiation date | Apr 17, 2017 |
| Report date | May 10, 2017 |
| Termination date | Jun 18, 2019 |
| City | Westbury |
| State | NY |
| Country | United States |
| FEI number | 1000306997 |
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: