Prenatal Vitamins, Iron Recalled
Ethex Generic-Drug Recall Expands to Prenatal Vitamins
Feb. 4, 2009 -- Ethex Corp. has extended its voluntary generic drug recall to include prescription prenatal vitamins and iron supplements, the FDA today announced.
In addition, the generic-drug recall, which was previously only aimed at wholesalers, now specifically includes patients using the following Ethex drugs:
Morphine Sulfate Extended-Release Tablets 15 mg, 30 mg & 60 mg (all strengths)
- Morphine Sulfate Immediate-Release Tablets 15 mg & 30 mg (all strengths)
- Dextroamphetamine Sulfate Tablets 5 mg & 10 mg (all strengths)
- Isosorbide Mononitrate Extended-Release Tablets 30 mg, 60 mg & 120 mg (all strengths)
- Propafenone HCl Tablets 150 mg, 225 mg & 300 mg (all strengths)
Questions about these drugs should be addressed to Ethex Customer Service at 800-748-1472, faxed to Ethex Customer Service at 314-646-3788, or emailed to email@example.com. Representatives are available Monday through Friday, 8 am to 5 pm Central time.
Nobody is known to have been injured by the products. The reason for the "precautionary" recall is that "the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice."
But for the vitamins, supplements, and most of the generic drugs, the recall still applies only to wholesalers, not to consumers.
"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," the FDA says in a news release.
The news release also warns patients that they "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."
The recalled prescription prenatal vitamin products are:
- Advanced NatalCare Tablets
- Advanced-RF NatalCare Tablets
- Cal-Nate Tablets
- CareNatal DHA Tablets
- ComBgen 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
The recalled prescription iron supplement products are:
- Anemagen Caplets
- Anemagen Forte Caplets
- Conison Capsules
- Fe-Tinic 150 Forte Capsules
Today's recall extends a long list of prescription generic drugs that Ethex recalled from wholesalers only on Jan. 28.
Ethex Corp. of St. Louis is a subsidiary of KV Pharmaceutical Co.