Drug Enforcement D-471-2014

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.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
Product quantity
900 Tablets
Reason for recall
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.
Recall initiation reason
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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
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Codes & Dates

Recall number
D-471-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
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.
More code info
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