Elite Pharmaceuticals Inc (ELTP)

[lasers]

EMBEDA

http://www.embeda.com/

IMPORTANT INFORMATION FOR PATIENTS AND PRESCRIBERS

King Pharmaceuticals Inc., a wholly owned subsidiary of Pfizer, has voluntarily recalled from U.S. wholesalers and retailers all dosage forms of EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII because a pre-specified stability requirement was not met during routine testing.

Available data suggest that the issue is unlikely to pose a safety risk to patients using EMBEDA as prescribed. We continue to monitor this issue.

Patients can continue taking EMBEDA as prescribed. Patients should not stop taking EMBEDA without consulting their doctor about switching to another opioid medicine. Before patients run out of EMBEDA, they should consult with their health care provider about another treatment for their pain.

Pfizer is committed to making EMBEDA available to physicians and patients as soon as possible once this stability issue is resolved. We apologize for any inconvenience that this recall may cause.

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http://www.aboutlawsuits.com/embeda-recall-manufacturing-problems-16891/

This is the fourth time in about the last year that there has been a recall for Embeda. The most recent recall was announced by King Pharmaceuticals in a letter sent to customers on November 1, 2010. Again, the drug failed to meet specifications for sustained release of its active ingredient. However, that recall only affected two lots.

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Longs will soon come to realize the significance of additional $multi-million revenue generation when the 2-bead methodology Patent Application 20100098771 is granted Patent Grant status. The impact of this technology will be for the successful commercial size manufacturing batches due to a more forgiving pharmaceutical engineering operations. As I have previously posted it is one thing to make bench scale batch sizes and an order of magnitude more difficult to make repeated successful much larger commercial size batches. Pfizer’s King Embeda 1-bead agonist/antagonist manufacturing difficulties and repeated recalls is a prime example. As well Purdue’s temporary replacement of their unsuccessful 1-bead agonist/antagonist Oxycontin with a hard shell technology agonist only.