FDA recall D-802-2014

Aidapak Services, LLC · Class II · drug

Product

PHENOL, LOZENGE, 29 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00068021918.

Reason for recall

Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014; VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, EXP: 5/22/2014.

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-802-2014