Teva Pharmaceuticals Recall: Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles
Teva Pharmaceuticals Recall: Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Teva Pharmaceuticals; Product: Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, In
| Recalling firm | Teva Pharmaceuticals |
|---|---|
| Product | 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, NJ 07054, USA, NDC: 0591-3693-19 |
| 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 potential for additional tablets to be below specification. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Nationwide in the US |
| Recall initiated | 20170531 |
| Recall number | D-0960-2017 |
| Category | drug |
| State | PA |
| Country | United States |
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