Recalls / Class II
Class IID-900-2014
Product
ATORVASTATIN CALCIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378201577.
- Affected lot / code info
- ATORVASTATIN CALCIUM, Tablet, 10 mg has the following codes: Pedigree: AD33897_4, EXP: 5/9/2014; Pedigree: AD49582_7, EXP: 5/16/2014; Pedigree: W002774, EXP: 6/6/2014; Pedigree: W003095, EXP: 6/12/2014;
Why it was recalled
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
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 990 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-900-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.