FDA Drug Recalls

Recalls / Class II

Class IID-702-2014

Product

aMILoride HCl Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980015101

Affected lot / code info
aMILoride HC, Tablet, 5 mg has the following codes Pedigree: AD60272_55, EXP: 5/22/2014; Pedigree: W003686, EXP: 6/26/2014.

Why it was recalled

Labeling: Label Mixup; aMILoride HCl Tablet, 5 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_37, EXP: 5/22/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003764, EXP: 6/26/2014.

Recalling firm

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

Distribution

Quantity
200 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-702-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.