Idahoans affected by pharmaceutical recall

Summary

The drug maker Ethex sent out oversized tablets, some double the expected dosage. The recall includes dextroamphetamine, morphine and a couple of heart medications.

Story Created: Nov 20, 2008 at 11:52 AM MST

Story Updated: Dec 18, 2008 at 2:42 PM MST

Idahoans affected by pharmaceutical recall
BOISE - Some people in the Treasure Valley are getting a surprise in the mail, a letter from their pharmacist about a potentially dangerous drug recall.

Rite Aid is one of the many area pharmacies affected the recall. In a letter to patients, the pharmacy says drug manufacturer Ethex Corporation botched recent lots of 10 different products, sending oversized tablets that could have twice the expected dosage.

Mark Phillips, the assistant director of pharmacy at Saint Alphonsus, says the mistake could have some serious consequences.

“The medication tablets were about twice the size as they should have been, therefore containing about twice as much drug as they should have,” Phillips said. For example, a double dose of morphine (one of the prescriptions being recalled) could cause extreme drowsiness, confusion, fainting and worse:

“Problems breathing, stopping breathing, even death. That's rare but certainly a possibility,” Phillips said.

The Ethex recall includes dextroamphetamine, (commonly taken for ADHD and narcolepsy), morphine (a pain reliever) and heart drugs propafenone and isosorbide. According to the U.S. Food and Drug Administration's website, Ethex has had three drug recalls since June.

Rite Aid spokeswoman Cheryl Slavinsky says all the recalled product has been pulled from the shelves, and they've sent a letter to all customers that have filled a prescription for the drugs in the last 12 months. When asked how the company felt about one of their suppliers making three recalls in the last six months, Slavinsky said she didn't know that was the case.

“I really can't speak to that,” Slavinsky said.

A call to Ethex Corporation was transferred to parent company, KV Pharmaceutical. But the spokeswoman was out of the office, and has not returned messages left Thursday afternoon. An office administrator referred the call back to Ethex.

A full list of the recalled products- their dosage, lot numbers and manufacture dates can be found in Ethex's news release below:


November 7, 2008 – ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic /non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.

Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.

The lots involved in the recall were all shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010

Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011

Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011

Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “331” with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “332” with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “333” with a bisect on the reverse.

The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed “E” bisecting “30” on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed “E” bisect “60” on one side and bisect on the other side.

The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with “15” on one side and an “E” on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a “15” on one side and an “ETH” on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with “30” on one side and an “ETHEX” on the reverse.

The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge, orange mottled tablet debossed “ETHEX” and “312” on one side and double-scored on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers who have received any inventory of the recalled product lots with instructions for returning the recalled products. The notification also includes instructions for the retailers/pharmacies to contact consumers who were dispensed these drugs for replacement of the product and/or refund. If the wholesalers and retailers have not already done so, they are urged to contact the number below regarding procedures for returning the recalled products. If consumers have any questions about the recall, they should call the number listed below for customer inquiries, their physician, their pharmacist or other health care provider.

Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8:00 am to 5:00 pm Central Standard Time (CST).

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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