Recalls / Class III
Class IIID-688-2013
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 #: 6103883, Exp 10/2013
Why it was recalled
Failed Impurities/Degradation Specification
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
- 80,480 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-05-21
- FDA classified
- 2013-07-08
- Posted by FDA
- 2013-07-17
- Terminated
- 2015-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-688-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.