Drug product
LANTHANUM CARBONATE Chew Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092025290
D-615-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 405 Chew Tablets
- Official record key
drug-enforcement:D-615-2014
Official wording
Reason: Labeling: Label Mixup; LANTHANUM CARBONATE Chew Tablet, 500 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_31, EXP: 5/13/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD32757_53, EXP: 5/14/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: W002712, EXP: 6/6/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68
Code information: LANTHANUM CARBONATE, Chew Tablet, 500 mg has the following codes Pedigree: AD32764_5, EXP: 5/13/2014; Pedigree: AD32764_8, EXP: 5/14/2014; Pedigree: W002790, EXP: 6/6/2014; Pedigree: W003410, EXP: 6/19/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled