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Missouri Department of Health & Senior Services
06/21/05

FROM:
Julia M. Eckstein
Director

SUBJECT: FDA Advises Consumers about Recalled Drugs from Able Laboratories

The Food and Drug Administration (FDA) is taking action to ensure the public is fully aware that Able Laboratories of Cranbury, NJ, 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.

The names of the recalled drugs and their imprint codes can be found at the FDA website http://www.fda.gov/bbs/topics/NEWS/2005/NEW01182.html . Imprints are marks (usually letters and numbers) found on the surfaces of drugs. If you have one of the drugs with one of the corresponding
imprint codes, your drug is covered by the Able Laboratories recall.

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. An investigation is underway to identify all the repackers and wholesalers who distribute these drugs from Able Laboratories. In the meantime, the best way for consumers to know whether they have a product produced by Able Laboratories is to check
the list provided at the FDA website and either contact their pharmacist or compare the imprint numbers on their individual tablets with the imprint numbers.

Consumers with questions may contact Able Laboratories at 1-800-982-2253. Persons wanting to report any adverse events to the FDA may contact FDA's MedWatch office at 1-800-FDA-1088.


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