D-0290-2015 Class II Terminated
FDA drug recall D-0290-2015 was initiated by Fresenius Kabi USA, LLC on Nov 12, 2014 and is designated Class II. Reason for recall: Defective Container: Vials may be missing stoppers. The recall status is terminated (terminated Mar 8, 2016). Affected quantity: 92,125 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 17, 2014
- Initiation Date
- Nov 12, 2014
- Termination Date
- Mar 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92,125 vials
Product Description
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
Reason for Recall
Defective Container: Vials may be missing stoppers.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0290-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026