Drug product
Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
D-0736-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,644 vials
- Official record key
drug-enforcement:D-0736-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 31329150B, exp. date 06/2022
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility