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2007 Safety Alert: Caffeine Citrated, Powder, Purified |
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The following information is from Spectrum Laboratory Products, Inc. Contact the company for a copy of any referenced enclosures.Caffeine Citrated, Powder, Purified Recall Quick Facts Product Name: Caffeine Citrated, Powder, Purified Spectrum Catalog Number: CA110 Lots Affected: TS0225, UK0821 and VI1203 Reason for Recall: Caffeine Citrated, Powder, Purified, Spectrum Catalog # CA110 carries the following specification on its label: “Assay (as Caffeine): ….. Approx. 50%.”. However, in some patients blood levels of Caffeine Citrated were significantly lower than would be expected. For this reason, DO NOT CONTINUE TO COMPOUND WITH THIS PRODUCT. Health Hazard Assessment: Caffeine Citrated is indicated for the short term treatment of apnea of prematurity in infants between 28 and younger than 33 weeks gestational age. It is a bronchial smooth muscle relaxant, a CNS stimulant, a cardiac muscle stimulant and a diuretic. Caffeine Citrate oral solution is compounded as a clear, colorless, aqueous solution. The use of sub-potent Caffeine Citrate may lead to sub-therapeutic blood levels and an unacceptably risk of apnea (short periods when premature babies stop breathing). Efficacy for other therapeutic uses has not been evaluated. Actions to Take:
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