FDA recall D-861-2014

Aidapak Services, LLC · Class II · drug

Product

DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115981101.

Reason for recall

Labeling: Label Mixup: DIGOXIN, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD21846_34, EXP: 5/1/2014; DESMOPRESSIN ACETATE, Tablet, 0.1 mg, NDC 00591246401, Pedigree: AD46426_16, EXP: 5/15/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 00603548221, Pedigree: AD60264_1, EXP: 5/22/2014; LIOTHYRONINE SODIUM,

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-861-2014