FDA recall D-989-2014

Aidapak Services, LLC · Class II · drug

Product

PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603506321.

Reason for recall

Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD46257_19, EXP: 5/15/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD60272_25, EXP: 5/22/2014; MONTELUKAST SODIUM, CHEW Tablet, 4 mg, NDC 00006071131, Pedigree: AD76639_11, EXP: 5/31/2014.

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-989-2014