neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South...
FDA Recall #D-0982-2023 — Class II — July 14, 2023
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.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6,468 Syringes
Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated