Drug product
CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 31604014271
D-543-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 546 Capsules
- Official record key
drug-enforcement:D-543-2014
Official wording
Reason: Labeling: Label Mixup; CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: W002653, EXP: 6/5/2014; MODAFINIL, Tablet, 200 mg, NDC 00603466216, Pedigree: W003779, EXP: 6/26/2014; NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: W003739, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN, Capsule, 500 mg/40
Code information: CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg has the following codes Pedigree: W002692, EXP: 6/5/2014; Pedigree: W003715, EXP: 6/26/2014; Pedigree: W003716, EXP: 6/26/2014; Pedigree: AD60240_11, EXP: 5/22/2014; Pedigree: W002693, EXP: 6/5/2014; Pedigree: AD46257_13, EXP: 5/15/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled