FDA recall D-887-2014

Aidapak Services, LLC · Class II · drug

Product

ROSUVASTATIN CALCIUM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00310075590.

Reason for recall

Labeling: Label Mixup: ROSUVASTATIN CALCIUM, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: IBUPROFEN, Tablet, 400 mg, NDC 67877029401, Pedigree: W002577, EXP: 6/3/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD21846_49, EXP: 5/1/2014.

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-887-2014