D-0097-2019 Class II Terminated
FDA drug recall D-0097-2019 was initiated by Teva Pharmaceuticals USA on Aug 6, 2018 and is designated Class II. Reason for recall: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. The recall status is terminated (terminated Feb 13, 2020). Affected quantity: 3,785 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 31, 2018
- Initiation Date
- Aug 6, 2018
- Termination Date
- Feb 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,785 bottles
Product Description
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 by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Reason for Recall
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Distribution Pattern
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Code Information
Lot #: a) 1291192A, Exp 01/2020; b) 1291193A, Exp 01/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0097-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026