Recalls / Class III
Class IIID-379-2014
Product
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
- Affected lot / code info
- Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
Why it was recalled
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 215,340 vials
- Distribution pattern
- Nationwide, Puerto Rico, Canada, New Zealand
Timeline
- Recall initiated
- 2013-12-06
- FDA classified
- 2013-12-18
- Posted by FDA
- 2013-12-25
- Terminated
- 2015-05-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-379-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.