Recalls / Class II
Class IID-1007-2014
Product
TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210301.
- Affected lot / code info
- TACROLIMUS, Capsule, 1 mg has the following codes: Pedigree: AD37056_1, EXP: 5/10/2014; Pedigree: AD56917_7, EXP: 5/21/2014; Pedigree: AD73627_14, EXP: 5/30/2014; Pedigree: W003704, EXP: 6/26/2014; Pedigree: W002508, EXP: 6/3/2014; Pedigree: W003049, EXP: 6/12/2014; Pedigree: W003352, EXP: 3/31/2014.
Why it was recalled
Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 5 mg, NDC 29300012601, Pedigree: AD34934_7, EXP: 5/10/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD56917_4, EXP: 5/21/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD73627_11, EXP: 5/30/2014; ATOMOXE
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 700 Capsules
- 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-1007-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.