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1/31/2017

Ferrous Sulfate Oral Pediatric Drops

Reason for the Shortage

    • Several liquid products were affected by a recall from PharmaTech due to potential contamination from B. cepacia. These included the ferrous sulfate liquid products from Akorn and Major. FDA issued a MedWatch report with the products affected. This is available on their website: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm515625.htm.

Available Products

    • Enfamil Fer-In-Sol oral drops, Mead-Johnson, 15 mg/mL, 50 mL bottle, 1 count, NDC 00087-0740-02
    • Fer-Iron oral drops, Major, 15 mg/mL, 50 mL bottle, 1 count, NDC 00536-0710-80
    • Iron Drops oral drops, Patrin Pharma, 15 mg/mL, 50 mL bottle, 1 count, NDC 39328-0057-50
    • RX Choice Ferrous Sulfate oral drops, Akorn, 15 mg/mL, 50 mL bottle, 1 count, NDC 50383-0627-50
    • Ferrous Sulfate oral drops, Major, 15 mg/mL, 50 mL bottle, 1 count, NDC 00904-6060-50

Estimated Resupply Dates

    • All presentations are available.

Updated

Updated January 31, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. Created August 11, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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