Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Caraco Pharmaceutical Laboratories has alerted the Food and Drug Administration (FDA) and is issuing a consumer-level recall of all tablets of the generic medication Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The drugs are being voluntarily recalled. The tablets may differ in size and could contain more or less of the active ingredient, digoxin.

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Another prescription heart medication has been pulled from the market because some pills have been found to be oversized. Those oversized pills may contain slightly higher levels of the active ingredient than specified, according to the Food and Drug Administration (FDA), which issued the alert.

Watson Pharmaceuticals, Inc., announced the voluntary recall of Propafenone HCL 225 mg tablets sold in 100-count bottles in the United States. The affected tablets were sold to customers between October 15, 2008 and November 26, 2008. No other strengths or lots were affected and the company does not anticipate any product shortages as a result of this recall.

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Two subsidiaries of KV Pharmaceutical, ETHEX Corporation and Ther-Rx Corporation, have issued an update to an announcement issued just days earlier, expanding even more on a long list of generic drug products recalled at the wholesale or retail levels. This new release includes the nationwide recall at the wholesale level of prescription prenatal and iron supplements.

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ETHEX Corporation has expanded two previous voluntary recalls initially issued in 2008 to include more than 60 generic drug products at either the wholesale level or retail level as a safety precaution. The generic products may have been manufactured under conditions that “did not sufficiently comply with current Good Manufacturing Practices,” according to a press release issued by the FDA.

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On October 8, John Dingell (D-MI), chairman of the U.S. House Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of that committee’s Subcommittee on Oversight and Investigations, wrote a letter to the U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach to request more information concerning the FDA’s procedure for examining manufacturing facilities of the generic drug manufacturer Actavis after several of the company’s products were recalled.

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Many previous Digitek consumers have steered away from Digitek after the recall. However, as Digitek has lost consumers, Lannett Company has only reaped the benefits.

Sales for Lannett’s digoxin, a generic form of Digitek, still have been strong since the recall of Digitek in April of this year.

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Actavis Totowa, the drug manufacturer of Digitek, just announced a voluntary recall, to the retail level, of more than 65 generic drug products manufactured at its Little Falls, New Jersey, facility, according to a release on the company web site. This recall follows an inspection conducted by the Food & Drug Administration, earlier this year, which revealed that operations at the New Jersey facility did not meet FDA standards.

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A generic form of digitalis – a heart drug – has been recalled in an unusual action that requires pharmacists to personally notify all customers who have purchased it.

Doctors prescribe the drug, Digitek, to treat heart failure and abnormal heart rhythms.

Actavis Totowa, a Totowa, N.J., manufacturer, recalled Digitek after consulting with the Food and Drug Administration. Actavis makes Digitek for Mylan Pharmaceuticals of Pittsburg, Pa.

Actavis counsel John LaRocca said the company recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness. An FDA statement said: “These tablets may contain twice the approved level of active ingredient than is appropriate.”

Double-strength tablets could lead to toxic levels of digitalis in patients with renal failure.

“We had some concerns about the process,” LaRocca said. He said the company knew of no deaths linked to Digitek use but Actavis and the FDA had received 11 complaints about side effects since 2006.

Actavis has asked pharmacists to instruct consumers to return all unused Digitek pills and to consult their physicians. While recalls often result in the removal of drugs from pharmacy shelves, consumers seldom receive personal notification.

At North Shore Pharmacy in Huntington, supervising pharmacist Ron Wood said, “We never keep the generic [Digitek] in stock, so it [the recall] doesn’t apply.”

Joel Bassuk, pharmacist at Raindew Pharmacy in Manhasset, said he received the recall notice yesterday but he only has about five customers who use the drug.

“They said to immediately examine your inventory and discontinue all lots,” Bassuk said, noting he has had no reports of adverse side effects.

CVS spokesman Mike DeAngelis said the chain had removed all Digitek from its stores. “We went back to see which patients had prescriptions over the past 12 months and contacted them,” DeAngelis said.

SOURCE: Newsday