Drug product
Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
D-0745-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,184 vials
- Official record key
drug-enforcement:D-0745-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 31329169B, 31329231B, exp. Date 06/2022
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility