D-0982-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2023
- Initiation Date
- July 14, 2023
- Termination Date
- March 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,468 Syringes
Product Description
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
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Distribution Pattern
Nationwide in the USA
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.