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U.S. Department of Health and Human Services

Safety

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Caffeine Citrated, Powder, Purified Recall Quick Facts

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:

  • Do not use or distribute any remaining Caffeine Citrated, Powder, Purified from the lots shown above.
  • Complete the enclosed Product Use & Disposition Survey and return it to Spectrum in the post-paid envelope provided. Thank you, in advance, for completing this very important required step.
  • Contact Spectrum to arrange credit or replacement of unused product. Shipping will be arranged at no cost to you, if there is a need to return the product to Spectrum.

Contact Information:

  • To arrange to return product: Call Customer Service (800) 772-8786, Press one for Sales and refer to CAll0, Caffeine Citrated recall. Fax (310) 516-7512
  • Technical questions: Call Stephen Newton (800)791-3210, Ext. 349
  • Regulatory questions: Call Kaveh Vakili (800) 772-8786, Ext. 675.