FDAFDA · Food and drugs·Recall number D-379-2014
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11
Published December 25, 2013 · Recall initiated: December 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide, Puerto Rico, Canada, New Zealand
- Lot
- Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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