FDA recall D-0096-2019

Product

Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), 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

Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

Key facts

Status

Terminated

Initiation date

2018-08-06

Report date

2018-10-31

Termination date

2020-02-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0096-2019