FDA Drug Recalls

Recalls / Class II

Class IID-323-2014

Product

Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01

Affected lot / code info
The following product was affected: AHP Lot #: 130007 Expiration Date: 01/31/2014 Carton NDC #: 68084-633-01 Single Dose NDC #: 68084-633-11

Why it was recalled

Subpotent

Recalling firm

Firm
American Health Packaging
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188

Distribution

Quantity
1536 cartons
Distribution pattern
Nationwide

Timeline

Recall initiated
2013-08-02
FDA classified
2013-12-05
Posted by FDA
2013-12-11
Terminated
2015-06-26
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-323-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls