Drug recall
PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc…
FDA recall event 75300 · Class III · Teva Pharmaceuticals USA
Key facts
| Event ID | 75300 |
|---|---|
| Recall numbers | D-0109-2017, D-0110-2017, D-0111-2017 |
| Recalling firm | Teva Pharmaceuticals USA |
| Product type | Drugs |
| Products | PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA…, PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA…, PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. |
| Initiation date | Sep 22, 2016 |
| Report date | Oct 26, 2016 |
| Termination date | May 5, 2017 |
| City | North Wales |
| State | PA |
| Country | United States |
| FEI number | 3003092769 |
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 · Source date: