FDA recall D-900-2014

Aidapak Services, LLC · Class II · drug

Product

ATORVASTATIN CALCIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378201577.

Reason for recall

Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: AD30180_4, EXP: 5/8/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD49399_4, EXP: 5/16/2014; ASPIRIN, CHEW Tablet, 81 mg, NDC 00536329736, Pedi

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-900-2014