Drug product
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 63323-365-01.
D-0866-2016
Product summary
- Event
- Event 73811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 355,150 vials
- Official record key
drug-enforcement:D-0866-2016
Official wording
Reason: Failed Impuities/Degradation Specifications
Code information: Lot # 6108322; Exp. 04/16 Lot # 6108824; Exp. 07/16
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Unknown
Failed Impuities/Degradation Specifications