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FDA advises
consumers about recalled drugs from Able Laboratories
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[JUNE 9, 2005]
ROCKVILLE,
Md. -- The Food and Drug Administration is taking action to ensure
that the public is fully aware that Able Laboratories of Cranbury,
N.J., is conducting a nationwide recall of all of its manufactured
drugs (mostly generic prescription drugs, including drugs containing
acetaminophen) because of serious concerns that they were not
produced according to quality assurance standards. Able Laboratories
has ceased all current production.
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"The FDA continues to evaluate the situation at Able Laboratories to
determine the safety and quality of their products and will update
the public on our findings as necessary," said Margaret O'K. Glavin,
associate commissioner for regulatory affairs. "In the meantime, the
agency recommends that people who have been taking drugs produced by
this firm speak with their health care provider or pharmacist to
obtain a replacement drug product. Consumers should continue taking
the medication until they have spoken with their health care
provider. In many cases the risk of suddenly stopping needed
medication before getting replacement drugs may outweigh the risk of
continuing to use the recalled products."
The list below provides the names of the recalled drugs and their
imprint codes. Imprints are marks (usually letters and numbers)
found on the surfaces of drugs. If you have one of the drugs listed
below with one of the corresponding imprint codes, your drug is
covered by the Able Laboratories recall.
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 Liquid products that are being recalled can be identified by the
lot numbers printed on their packaging.
It is important to note that this recall only applies to the
drugs produced by Able Laboratories -- and not to the same drugs
produced by other manufacturers.
Able Labs generic product labels include Ivax, Hawthorn, Cypress
and Breckenridge.
[Click
here to view a complete list of recalled Able Lab drugs.]
[U.S. Food
and Drug Administration news release]
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