D-1234-2015 Class II Terminated
FDA drug recall D-1234-2015 was initiated by Fresenius Kabi USA, LLC on Jun 4, 2015 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation The recall status is terminated (terminated May 19, 2016). Affected quantity: 7,593 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 22, 2015
- Initiation Date
- Jun 4, 2015
- Termination Date
- May 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,593 vials
Product Description
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Distribution Pattern
Nationwide,Hawaii, and Puerto Rico
Code Information
Lot #: 6109469, 6109470, Exp 10/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1234-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026