Reported Oct 31, 2018 · Terminated
Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only
- Manufactured byActavis Laboratories FL, Inc., Fort Lauderdale, FL 33314
- Distributed byActavis Pharma, Inc., Parsippany, NJ 07054
- Lot codes and dates
Lot #: a) 1291192AExp 01/2020b) 1291193AExp 01/2020
- Amount recalled
- 3,785 bottles
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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