Spectrum Laboratory Products, Inc, (Spectrum), Gardena, California, is initiating a voluntary nationwide recall of Caffeine Citrated, Powder, Purified, after receiving a complaint about potential sub potency.
Caffeine Citrated is a cerebral and respiratory stimulant used primarily to treat idiopathic apnea of prematurity. Blood levels of caffeine in patients were determined to be significantly lower than would be expected.
The use of sub-potent compounded preparations made may lead to sub-therapeutic caffeine blood levels and an unacceptable risk of respiratory depression. FDA has been apprised of this action.
Caffeine Citrated, Powder, Purified, is identified as Catalog Number CA110. Recalled lots include the following: TS0225, UK0821 and VI1203.
Pharmacies that have used the above lots of Caffeine Citrated, Powder, Purified, should stop using it and contact Spectrum to make arrangements to return it. Caffeine Citrated, Powder, Purified, 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.
No illnesses or injuries related to this product have been reported to date.
Spectrum is notifying its distributors and customers by telephone and recall letter and is arranging for return of all recalled products.
Consumers with questions may contact Stephen Newton at 1-800-791-3210, Ext. 349
Pharmacies are urged to examine their supplies for any of the recalled Caffeine Citrated, Powder, Purified, and immediately discontinue its use. Patients and consumers who suspect that they have received medications in any dosage form made from the three lot numbers of Caffeine Citrated, Powder, Purified, that are being recalled, should contact their pharmacy or physician. Users should also notify FDA of any complaints or problems associated with these products. Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch