Status
Terminated
Drug Enforcement D-688-2013
Failed Impurities/Degradation Specification
Classification
Class III
Report Date
July 17, 2013
Termination Date
May 11, 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
- 80,480 vials
- Reason for recall
- Failed Impurities/Degradation Specification
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
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-688-2013
- Event ID
- 65213
- Recall initiation date
- May 21, 2013
- Center classification date
- July 8, 2013
- Code info
- Lot #: 6103883, Exp 10/2013
- More code info
- —