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SafetyAlerts
September 27, 2000

649 Various Rx and OTC Products Recalled

First public notice issued by FDA of 'completed recall'...

Carmel, IN (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Pharmaceutical Corporation of America has recalled 649 various Rx and OTC products because of current good manufacturing deviations, including but not limited to lack of control to prevent beta-lactam antibiotic cross contamination.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
649 various Rx and OTC products.

Recall #D-471-0.

CODE
All products and package sizes bearing a PCA (Pharmaceutical Corporation of America) label except those with a lot number ending in RA, RB, or RC.

REPACKER
Pharmaceutical Corporation of America, Carmel, Indiana.

RECALLED BY
Repacker, by letter on March 13, 2000. Firm-initiated recall **complete.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION
Nationwide.

QUANTITY
3,846,600 bottles were distributed.

Questions concerning this recall should be directed to FDA at 1-888-463-6332

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.