Reported Jul 19, 2017 · Terminated
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc.,…
Teva Pharmaceuticals
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals · 425 Privet Rd · Horsham, PA · 19044-1220
Is this the product you have?
- Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only
- Manufactured byActavis Laboratories FL, Inc., Fort Lauderdale
- FL 33314 USA Distributed byActavis Pharma, Inc., Parsippany, NJ 07054, USA
- NDC0591-3693-19
- Lot codes and dates
- Lot
1160682AEXP. 06/18
- Lot
- Amount recalled
- 360 bottles
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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