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Hazard Warnings!


From the August 11, 1999 issue

A liquid ferrous sulfate product, manufactured and distributed by Hi-Tech Pharmacal Company, Inc., is labeled on the front panel as both "ferrous sulfate solution" and "iron supplement drops." The actual strength of this product is ferrous sulfate 75 mg (15 mg elemental iron) per 0.6 mL, similar to other ferrous sulfate products labeled as "drops." Use of the term "ferrous sulfate solution" is ambiguous since there is no such product. Ferrous sulfate drops have about three times as much iron per mL as ferrous sulfate elixir or about seven times as much as ferrous sulfate syrup (FER-IN-SOL). In a recently reported case, the Hi-Tech product was dispensed when ferrous sulfate elixir was prescribed. A child received several incorrect doses but the person administering the medicine soon noticed the appearance and packaging of the liquid was different from previously used iron products. They contacted the dispensing pharmacy and the error was recognized before the child was harmed. ISMP has contacted the company about this problem and they've forwarded the report to their labeling and regulatory affairs group. Please inspect drug storage areas to determine if this product is present at your practice site. If so, replace immediately with another manufacturer's ferrous sulfate drops.

Hi-Tech Ferrous Sulfate

Small volume parenteral vials of potassium acetate injection, made by American Pharmaceutical Partners (formerly manufactured by Fujisawa), are in danger of being confused with the company's Lypholyte-II multiple electrolyte solution. These products are likely to be found near one another during preparation of TPNs, etc. and they have similar color schemes and packaging. Under certain circumstances, a mix-up could prove fatal. We've communicated our concern to the manufacturer and they've promised to get back to us. In the mean time, we recommend that you seek out these products and consider an alternative vendor for one of them if necessary.

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