FDA Drug Recalls

Recalls / Class II

Class IID-580-2014

Product

LACTOBACILLUS GG Capsule, 10 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374

Affected lot / code info
LACTOBACILLUS GG, Capsule, 10 Billion Cells has the following code Pedigree: AD21965_19, EXP: 5/1/2014.

Why it was recalled

Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 10 Billion Cells may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD21965_22, EXP: 5/1/2014.

Recalling firm

Firm
Aidapak Services, LLC
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity
300 Cells
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-580-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.