Status
Terminated
Drug Enforcement D-701-2014
Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be potentially mislabeled as PROMETHAZINE HCL, Tablet, 25 mg, NDC 65162052110, Pedigree: W002578, EXP: 6/3/2014; VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD32579_1, EXP: 5/9/2014.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980015001
- Product quantity
- 509 Tablets
- Reason for recall
- Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be potentially mislabeled as PROMETHAZINE HCL, Tablet, 25 mg, NDC 65162052110, Pedigree: W002578, EXP: 6/3/2014; VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD32579_1, EXP: 5/9/2014.
- 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-701-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg has the following codes Pedigree: W002581, EXP: 6/3/2014; Pedigree: AD32345_1, EXP: 5/14/2014.
- More code info
- —