Washington -- The U.S. Food and Drug Administration said Spectrum Laboratory Products Inc. is recalling its Caffeine Citrated Powder due to potential potency issues.
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The Gardena, Calif., company distributes its purified caffeine powder -- a cerebral and respiratory stimulant -- nationwide, primarily to treat idiopathic apnea experienced by premature infants.
The company initiated the recall after blood levels of caffeine in patients were determined to be significantly lower than would be expected. The FDA said use of sub-potent compounded preparations could result in sub-therapeutic caffeine blood levels and an unacceptable risk of respiratory depression.
Recalled lots of the Caffeine Citrated Powder, Purified, include code numbers TS0225, UK0821 and VI1203.
The recalled product was distributed to pharmacies, hospitals, two universities, laboratories and pharmacy distributors. It can be identified by catalog number CA110 and the name "Caffeine Citrated, Powder, Purified" on the label.
Consumers with questions can contact company representative Stephen Newton at 800-791-3210, Ext. 349.
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