Class III
Terminated
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
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- December 6, 2013
- Posted
- December 25, 2013
- Recall Number
- D-379-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 215,340 vials
- Firm Location
- Lake Zurich, IL, United States
Reason for Recall
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Distribution
Nationwide, Puerto Rico, Canada, New Zealand
Lot / Code Info
Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
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