Recalls / Class II

Class IID-704-2014

Product

SODIUM BICARBONATE Tablet, 650 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980018210

Affected lot / code info

SODIUM BICARBONATE Tablet, 650 mg has the following code Pedigree: W002970, EXP: 6/11/2014.

Why it was recalled

Labeling: Label Mixup; SODIUM BICARBONATE Tablet, 650 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: W002974, EXP: 6/11/2014.

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

1,013 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-704-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.