Home
Safety
Recalls, Market Withdrawals, & Safety Alerts
Enforcement Reports

Recalls, Market Withdrawals, & Safety Alerts

Enforcement Reports

2012
2011
2010
2009
2008
2007
2006
2005
2004

-
Human Drug Product Recalls Pending Classification
FDA is conducting a pilot program seeking to expedite notifications of human drug product recalls to the public. In addition to the information about classified recalls found in the weekly Enforcement Report, the agency will include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. The information will be continue to be provided in a narrative format until FDA has decided upon the method to include it in the new Enforcement Report format. They will be reposted with their classification in the Enforcement Report once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.


Pending recalls for the September 11th, 2013 Enforcement Report


PRODUCT
Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5-650MG Tablets, Rx only, 500 Count Bottles (NDC 0591-2611-05)

CODE
706224A and 706225A. Exp. 04/15

RECALLING FIRM
Watson Laboratories Inc, Corona, CA

REASON FOR RECALL
Defective Container: Bottles may not have tamper evident seals properly seated