All Able Laboratories Drugs Recalled Due to Production Quality Concerns
On June 1, 2005 the FDA announced that the agency has issued a nationwide recall of all drugs -- mostly generic prescription drugs, including various drugs containing acetaminophen -- by Able Laboratories of Cranbury, NJ. The reason for this recall of Able drugs is the "serious concern" that these drugs were not produced according to quality assurance standards. Relatedly, it was announced that Able Laboratories has ceased all production of its drugs until, at least, the FDA has concluded its investigation of this emerging drug safety situation.
In more detail, the FDA gave notice of this nationwide recall of all drugs manufactured by Able Laboratories by means of an online alert sent June 1, 2005 from MedWatch, the FDA's safety information and adverse event reporting system. The Able recall covers mostly generic prescription drugs, including some that contain acetaminophen. These various drugs were manufactured under the following product labels: Able, Ivax, Major, Hawthorn, Cypress, and Breckenridge. A complete list of these recalled Able drugs, together with identifying tablet imprint codes or liquid formulation lot numbers, is available on the FDA's site:
The FDA has advised all patients who have been taking any of these Able drugs to contact their doctor or pharmacist for replacement products. The FDA emphasized that out that, because the risk associated with sudden discontinuation of a prescription medication in many cases outweighs the risk of using the recalled product, affected patients should continue taking their medication until they have had an opportunity to speak with their doctor or pharmacist about this Able drug recall.
According to the June 1, 2005 FDA announcement, additional information may be obtained by contacting Able Laboratories by telephone at 1-800-982-2253.
Any suspected adverse events related to a patient's use of the recalled Able drugs should be reported to the FDA's MedWatch program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
(Posted by: Tom Lamb)