Drug product
PHENOL, LOZENGE, 29 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00068021918.
D-802-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 Lozenges
- Official record key
drug-enforcement:D-802-2014
Official wording
Reason: Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014; VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, EXP: 5/22/2014.
Code information: PHENOL, LOZENGE, 29 mg has the following codes: Pedigree: AD49582_13, EXP: 5/16/2014; Pedigree: AD60428_4, EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled