ETHEX Corporation has recalled more lots of generic medicines because some pills may be oversized. In addition to previous recalls of morphine sulfate and dextroamphetamine, the new recall includes two cardiac drugs and additional lots and dosages of morphine and dextroamphetamine.
There is a possibility that some tablets may be oversized and contain up to double the amount of active medicine. Overdoses can cause serious medical problems including difficulty breathing and low blood pressure for morphine and rapid heart beat and high blood pressure for dextroamphetamine.
If you or the patient you are caring for has difficulty breathing, faints, becomes unresponsive, or has other signs of morphine overdose, call 911 and get medical help.
The new morphine recall adds:
- 15 mg extended release morphine tablets: green oval with “15″ on one side and “E” on reverse
- 15 mg immediate release morphine tablets: brown round pill with “15″ on one side and “ETH” on reverse
- 30 mg immediate release morphine tablets: brown capsule shape with “30″ on one side and “ETHEX” on reverse
The new dextroamphetamine recall is:
- 10 mg mottled orange beveled edge tablets with “312″ and “ETHEX” on one side and scoring on reverse
In addition to lots of morphine and dextroamphetamine which may be used in cancer care, significant numbers of lots of the heart medicines propafenone and isosorbide have been recalled. Check the FDA recall web page for dosages and lot numbers.
ETHEX Corporation has contacted wholesalers and retailers who received any of the recalled lots and has given them instructions to contact consumers who might have received the drugs with information on how to get replacements and refunds. However, patients and caregivers should check their own medicines and call their doctors or pharmacists if they have any concerns or questions at all about whether it is safe to take their medicine.
You can also contact ETHEX Customer Service at 1-800-748-1472. Customer service representatives are available Monday through Friday, 8:00 am to 5:00 pm Central Standard Time (CST).
If you have an adverse reaction to one of these drugs or a problem with product quality, you can also report them to the FDA’s MedWatch Program by calling 1-800-FDA-1088 or going to the FDA MedWatch website.
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.