Drug product
CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
D-471-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 900 Tablets
- Official record key
drug-enforcement:D-471-2014
Official wording
Reason: Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca) may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W002767, EXP: 6/6/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD60240_20, EXP: 5/22/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: AD73521_25, EXP: 5/30/2014.
Code information: CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca) has the following codes Pedigree: W002699, EXP: 6/5/2014; Pedigree: AD60240_27, EXP: 5/22/2014; Pedigree: AD73521_28, EXP: 5/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled