FDA recall D-983-2014

Aidapak Services, LLC · Class II · drug

Product

GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121.

Reason for recall

Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: PARICALCITOL, Capsule, 1 mcg, NDC 00074431730, Pedigree: W002667, EXP: 6/5/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000850, Pedigree: W003244, EXP: 6/17/2014; LACTOBACILLUS, Tablet, 0, NDC 64980012950, Pedigree: AD22865_1, EXP: 5/2/2014.

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-983-2014