Status
Terminated
Drug Enforcement D-615-2014
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
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- LANTHANUM CARBONATE Chew Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092025290
- Product quantity
- 405 Chew Tablets
- Reason for recall
- 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
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location & Firm
- Recalling firm
- Aidapak Services, LLC
- Address
-
14301 Se 1st St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-615-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- 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.
- More code info
- —