Drug recall
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories…
FDA recall event 77393 · Class I · Teva Pharmaceuticals
Key facts
| Event ID | 77393 |
|---|---|
| Recall numbers | D-0960-2017 |
| Recalling firm | Teva Pharmaceuticals |
| Product type | Drugs |
| Products | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the… |
| Initiation date | May 31, 2017 |
| Report date | Jul 19, 2017 |
| Termination date | Mar 29, 2018 |
| City | Horsham |
| State | PA |
| Country | United States |
| FEI number | 3004442422 |
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: