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

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