Drug product
DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115981101.
D-861-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 Tablets
- Official record key
drug-enforcement:D-861-2014
Official wording
Reason: Labeling: Label Mixup: DIGOXIN, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD21846_34, EXP: 5/1/2014; DESMOPRESSIN ACETATE, Tablet, 0.1 mg, NDC 00591246401, Pedigree: AD46426_16, EXP: 5/15/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 00603548221, Pedigree: AD60264_1, EXP: 5/22/2014; LIOTHYRONINE SODIUM,
Code information: DIGOXIN, Tablet, 0.125 mg has the following codes: Pedigree: AD22609_4, EXP: 4/30/2014; Pedigree: AD46426_22, EXP: 5/15/2014; Pedigree: AD62829_8, EXP: 5/23/2014; Pedigree: W003154, EXP: 6/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled