D-688-2013 Class III Terminated
FDA drug recall D-688-2013 was initiated by Fresenius Kabi USA, LLC on May 21, 2013 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specification The recall status is terminated (terminated May 11, 2015). Affected quantity: 80,480 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 17, 2013
- Initiation Date
- May 21, 2013
- Termination Date
- May 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80,480 vials
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
Reason for Recall
Failed Impurities/Degradation Specification
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 6103883, Exp 10/2013
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-688-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026