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Recall Observatory FDA recall evidence

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

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
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

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility