D-0867-2016 Class II Terminated
FDA drug recall D-0867-2016 was initiated by Fresenius Kabi USA, LLC on May 4, 2016 and is designated Class II. Reason for recall: Failed Impuities/Degradation Specifications The recall status is terminated (terminated Jan 23, 2017). Affected quantity: 40,280 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 1, 2016
- Initiation Date
- May 4, 2016
- Termination Date
- Jan 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,280 vials
Product Description
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
Reason for Recall
Failed Impuities/Degradation Specifications
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot # 6108831; Exp. 07/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0867-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026