Status
Terminated
Drug Enforcement D-379-2014
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Classification
Class III
Report Date
December 25, 2013
Termination Date
May 21, 2015
Product Information
- Product description
- 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
- Product quantity
- 215,340 vials
- Reason for recall
- Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Puerto Rico, Canada, New Zealand
Location & Firm
- Recalling firm
- Fresenius Kabi USA, LLC
- Address
-
3 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-379-2014
- Event ID
- 67054
- Recall initiation date
- December 6, 2013
- Center classification date
- December 18, 2013
- Code info
- Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
- More code info
- —