Drug product
TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210301.
D-1007-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 Capsules
- Official record key
drug-enforcement:D-1007-2014
Official wording
Reason: 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
Code information: 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.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled