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Caffeine Citrated, Powder, Purified

May 21, 2007

Audience: Hospital risk managers, pediatricians, pharmacists, other healthcare professionals

[Posted 05/21/2007] Spectrum and FDA informed healthcare professionals of a nationwide recall of 3 lots (TS0225, UK0821, and V11203) of Caffeine Citrated, Powder, Purified. The product was recalled because of complaints about potential sub potency. Caffeine Citrated is a cerebral and respiratory stimulant used primarily to treat idiopathic apnea of premature infants. Blood levels of caffeine in patients were determined to be significantly lower than would be expected. The use of sub-potent compounded preparations may lead to sub-therapeutic caffeine blood levels and an unacceptable risk of respiratory depression. Customers should examine their inventory, discontinue dispensing and using the product, quarantine the referenced lots of the product. and call the manufacturer to arrange to return the product for credit or replacement.

[May 17, 2007 - Recall Quick Facts - Spectrum]
[May 17, 2007 - Customer Survey - Spectrum]

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