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Recall Observatory FDA recall evidence

Drug product

EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.

D-0959-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
4,570 bags
Official record key
drug-enforcement:D-0959-2023

Official wording

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Code information: Lot: 36-240224, Exp. 7/16/2023; 36-242322, EXP. 7/24/2023; 36-242445, Exp. 7/25/2023; 36-243305, Exp. 7/27/2023; 36-243813, Exp. 7/31/2023; 36-246166, 36-246167, Exp. 8/3/2023; 36-247670, Exp. 8/9/2023; 36-248992, Exp.8/16/2023; 36-249468, Exp. 8/17/2023; 36-249590, Exp.8/18/2023; 36-251336, 36-251644, Exp. 8/27/2023; 36-251461, Exp. 8/28/2023; 36-255531, 36-255532, Exp. 9/7/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility