FDA Drug Recalls

Recalls / Class II

Class IID-1389-2012

Product

Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0

Affected lot / code info
Lots 6284, 60DI, 61AA.

Why it was recalled

Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.

Recalling firm

Firm
Physicians Total Care, Inc.
Notification channel
FAX
Type
Voluntary: Firm initiated
Address
12515 E 55th St Ste 100, N/A, Tulsa, Oklahoma 74146-6234

Distribution

Quantity
3 bottles
Distribution pattern
AK, NC, GA

Timeline

Recall initiated
2012-02-08
FDA classified
2012-06-19
Posted by FDA
2012-06-27
Terminated
2012-07-05
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1389-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.