D-540-2014 Class II Terminated
FDA drug recall D-540-2014 was initiated by Aidapak Services, LLC on July 2, 2013 and is designated Class II. Reason for recall: Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260, Pedigree: AD21846_24, EXP: 5/1/2014; CHOLEC… The recall status is terminated (terminated February 7, 2014). Affected quantity: 128 Tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2014
- Initiation Date
- July 2, 2013
- Termination Date
- February 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128 Tablets
Product Description
CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385060173
Reason for Recall
Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260, Pedigree: AD21846_24, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD60240_4, EXP: 5/22/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: W003020, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, ND
Distribution Pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Code Information
CAFFEINE Tablet, 200 mg has the following codes Pedigree: AD21846_37, EXP: 5/1/2014; Pedigree: AD60240_42, EXP: 5/22/2014; Pedigree: W003024, EXP: 6/12/2014; Pedigree: W003725, EXP: 6/26/2014.