Ethex NatalCare Recall: Understanding the 2009 Prenatal Vitamin Issue

In February 2009, the drug maker Ethex Corp. announced a voluntary retail and wholesale recall of its line of prescription prenatal vitamin tablets because of issues related to iron overdosing in customers. The tablets, sold under the NatalCare and other brand names, were developed as multivitamin and mineral supplements meant to meet mothers' nutritional needs during pregnancy and breastfeeding. Ethex recalled NatalCare vitamins voluntarily after

NatalCare Plus

• NatalCare Plus tablets can be identified by their oval shape and pink coating; one side contains the word "ETHEX," and on the other side the number 225 is embossed. The active vitamin ingredients are 4000 IU of vitamin A, 1.84 mg vitamin B1, 3 mg vitamin B2 (riboflavin), 20 mg vitamin B3 (niacin), 10 mg vitamin B6, 1 mg vitamin B9 (folic acid), 12 mcg vitamin B12, 120 mg vitamin C, 400 IU vitamin D3 and 22 mg of vitamin E. Active mineral compounds include 200 mg of calcium, 27 mg iron, 25 mg zinc and 2 mg of copper.

  NatalCare Plus also contains 13 inactive ingredients: carnauba wax, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, natural vanilla flavoring, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide and triacetin.

NatalCare Rx

• NatalCare Rx nutritional tablets contain 12 active vitamin compounds: 4000 IU of vitamin A, 1.5 mg vitamin B1, 1.6 mg riboflavin, 17 mg niacin, 7 mg vitamin B5 (pantothenic acid), 4 mg vitamin B6, 30 mcg vitamin B7 (biotin), 1 mg folic acid, 2.5 mcg vitamin B12, 80 mg vitamin C, 400 IU vitamin D and 15 IU of vitamin E. The medication's five mineral ingredients are 200 mg of calcium, 54 mg iron, 100 mg magnesium, 25 mg zinc and 3 mg of copper.

  NatalCare RX also contains 14 inactive ingredients: carnauba wax, croscarmellose sodium, ethyl vanillin, ethylcellulose, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide and triacetin.

NatalCare Three

• NatalCare Three prenatal nutritional tablets are beige in appearance. Tablets contain the following vitamins: 3000 IU of vitamin A, 1.8 mg vitamin B1, 4 mg riboflavin, 20 mg niacin, 25 mg vitamin B6, 1 mg folic acid, 12 mcg vitamin B12, 120 mg vitamin C, 400 IU vitamin D3 and 22 mg vitamin E. Mineral compounds include 200 mg of calcium, 28 mg iron, 25 mg magnesium, 25 mg zinc and 2 mg of copper.

  There are 28 inactive ingredients in NatalCare Three: acacia, ascorbyl palmitate, butylated hydroxyanisole, butylated hydroxytoluene, carnauba wax, citric acid, croscarmellose sodium, DL-alpha-Tocopherol, gelatin, hydrogenated vegetable oil, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, sodium ascorbate, sodium benzoate, sodium citrate, sodium lauryl sulfate, sorbic acid, starch, sucrose, titanium dioxide and triacetin.

Problems With Ethex NatalCare Ingredients

• According to the U.S. Food and Drug Administration, Ethex Corp. initiated the NatalCare recall, stating that its products "may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP)," without identifying the specific manufacturing problem.

  Other recalls of Ethex products in 2008 and 2009 involved potent medications. In each case, the recall notice cited tablets that were oversized, and therefore contained as much as twice the recommended dose of certain active ingredients.