Drug product
neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1
D-0982-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,468 Syringes
- Official record key
drug-enforcement:D-0982-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-239285, 36-239287, Exp. 7/11/2023; 36-239456, Exp. 7/12/2023; 36-239873, Exp. 7/13/2023; 36-240994, 36-240995, 36-240996, 36-240997, Exp. 7/18/2023; 36-241447, Exp. 7/20/2023, 36-242407, 36-242408, Exp. 7/25/2023; 36-246298, Exp. 8/3/2023; 36-248998, Exp. 8/16/2023; 36-251613, Exp. 8/28/2023; 36-251781, Exp. 8/29/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility