Drug product
FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104
D-518-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 Tablets
- Official record key
drug-enforcement:D-518-2014
Official wording
Reason: Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500
Code information: FAMOTIDINE Tablet, 20 mg has the following codes Pedigree: W003226, EXP: 6/17/2014; Pedigree: W003507, EXP: 6/21/2014; Pedigree: W003508, EXP: 6/21/2014; Pedigree: W003764, EXP: 6/26/2014; Pedigree: W003406, EXP: 6/19/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled