Drug recall
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)…
FDA recall event 84073 · Class III · Amneal Pharmaceuticals, Inc.
Key facts
| Event ID | 84073 |
|---|---|
| Recall numbers | D-0321-2020 |
| Recalling firm | Amneal Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. |
| Initiation date | Oct 16, 2019 |
| Report date | Nov 20, 2019 |
| Termination date | Nov 9, 2020 |
| City | Brookhaven |
| State | NY |
| Country | United States |
| FEI number | 3005263655 |
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: