September 27, 2000649 Various Rx and OTC Products
public notice issued by FDA of 'completed recall'...
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
This is the first public notice of
this Class II
recall issued by FDA.
649 various Rx and OTC products.
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.
Pharmaceutical Corporation of America, Carmel, Indiana.
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.
3,846,600 bottles were distributed.
Questions concerning this recall should be
directed to FDA at 1-888-463-6332
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