Recalls / Class II

Class IID-464-2014

Product

CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904323392.

Affected lot / code info

CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units has the following codes: Pedigree: W002610, EXP: 6/4/2014; Pedigree: AD54576_1, EXP: 5/20/2014.

Why it was recalled

Labeling: Label Mixup; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-labeled as DIGOXIN, Tablet, 125 mcg, NDC 00527132401, Pedigree: AD76675_4, EXP: 6/3/2014; or AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_4, EXP: 5/20/2014.

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

10,819 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-464-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.