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Hey everyone I'm not sure how many of you are affected by this,
but Able Laboratories, the manufacturer of Phentermine and about
40 other generic drugs (I think) has begun a recall of all its
products due to an investigation that turned up improper lab
testing, etc.

Here's a link to the article:

businessweek.com/ap/financialnews/D8A6EVTG0.htm?campaign_id=apn_home_down

Here's the article:

MAY. 19 3:58 P.M. ET Generic drug maker Able Laboratories Inc. said Thursday that an internal investigation found it violated certain laboratory testing norms, and therefore the company has decided to suspend all product shipments while it completes the review. Able Labs also said its chairman and CEO will resign and withdrew financial guidance.

The pharmaceutical firm's shares lost more than three quarters of their value after a trading halt was lifted by Nasdaq, plunging $18.36, or 74.5 percent, to $6.27 in recent activity. The stock had been trading between $17.60 and $26.49 over the past 52 weeks, and was up about 8 percent this year as of Wednesday's close.

Able recently recalled several products due to a variety of improper laboratory practices and deviation from standard operating procedures. The company notified the Food and Drug Administration of the problems and said in March that it would evaluate its practices in these areas.

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The company added Thursday that it found issues that will lead it to recall additional products and decided to stop all shipments as a precaution. However, Able said it does not yet know the extent to which its methods violated established operating procedures or manufacturing practices.

About two hours after announcing the findings of the review, Able said Chairman and Chief Executive Dhananjay G. Wadekar will step down and be succeeded by Robert G. Mauro, its president and chief operating officer, on an interim basis. The company expects Wadekar to continue as a consultant.

Able said it does not know what actions the FDA may take in response to today's announcement.

"This disruption in shipment, even if temporary, is expected to have a material effect on the company's ability to meet its sales goals and operating objectives," Able Labs said in a statement explaining its withdrawal of all financial guidance.

The protocols being used in the review have been established by outside consultants, the company said.

In recent months, Able recalled a batch of the blood-pressure treatment atenolol because the pills were subpotent and would only stay stable for six months, along with various drugs used to combat the nausea that comes with chemotherapy because of impurity and stability failures, according to an FDA Web site. These were all "class II" recalls, meaning the product could temporarily hurt a patient's health but there was low risk of serious consequences.

In January, the company recalled a large group of metronidazole capsules for adult acne because they were mislabeled. That recall was considered a less serious, class III recall.

Ian Mason
You can contact me at ian@shoppe.md