ETHEX Corp. has issued another big drug recall. This time ETHEX, a unit of KV Pharmaceuticals, is recalling several varieties of prescription infant vitamins and prescription iron supplement products that may have been manufactured under conditions that did not sufficiently comply with the Food & Drug Administration’s (FDA) current Good Manufacturing Practice (cGMP).
Last month, KV Pharmaceuticals suspended manufacturing and shipping of all of its products, including those made under the ETHEX name. That announcement followed an inspection that began in December by the FDA of the company’s operations and inventory. Because of the manufacturing problems cited by the FDA, ETHEX has issued several recalls in the past year.
This latest ETHEX recall involves the following:
Prescription Prenatal Vitamin Products:
Advanced NatalCare® Tablets
Advanced-RF NatalCare® Tablets
Cal-Nate™ Tablets
CareNatal™ DHA Tablets
ComBgen Tablets
ComBiRx™Tablets
NataCaps Capsules
NatalCare Gloss Tablets
NatalCare PIC Tablets
NatalCare PIC Forte Tablets
NatalCare Plus Tablets
NatalCare Rx Tablets
NatalCare Three Tablets
NataTab FA Tablets
NataTab RX Tablets
NutriNate® Chewable Tablets
NutriSpire™ Tablets
Prenatal MR 90 FE Tablets
Prenatal MTR w/Selinium Tablets
Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
Ultra NatalCare Tablets
Prescription Iron Supplement Products:
Anemagen Caplets
Anemagen Forte Caplets
Conison™ Capsules
Fe-Tinic™ 150 Forte Capsules
This recall has been issued at the wholesale/retail level. An ETHEX press release said patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.
ETHEX Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products. Any wholesaler inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.
Just last week, the problems at KV Pharmaceuticals prompted ETHEX to recall scores of generic drugs that might be defective. In December, the drug maker recalled a single lot of Hydromorphone HCl 2 mg tablets because some of them may have been oversized. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. Those medications included various lots and sizes of Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets and Dextroamphetamine Sulfate Tablets. That action followed an October recall of three lots of potentially oversized Dextroamphetamine Sulfate. And in June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.
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