FDA recall D-795-2014

Aidapak Services, LLC · Class II · drug

Product

ACARBOSE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054014025.

Reason for recall

Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the following drugs: ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: AD60240_57, EXP: 5/22/2014; TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: W002724, EXP: 6/6/2014; SILDENAFIL CITRATE, Tablet, 25 mg, NDC 00069420030, Pedigree: W003646, EXP: 6/25/2014; SEVELAMER CARBONATE, Tab

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-795-2014