Recalls / Class II

Class IID-471-2014

Product

CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260

Affected lot / 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.

Why it was recalled

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.

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

900 Tablets

Distribution pattern

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-16

Posted by FDA

2014-01-22

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-471-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.