FDA Drug Recalls

Recalls / Class II

Class IID-677-2014

Product

HYDROXYCHLOROQUINE SULFATE Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304029601

Affected lot / code info
HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg has the following code Pedigree: AD70629_10, EXP: 5/29/2014.

Why it was recalled

Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD70629_7, EXP: 5/29/2014.

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-677-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.