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Recall Observatory FDA recall evidence

Drug product

heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1.

D-0732-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
5207 bags
Official record key
drug-enforcement:D-0732-2023

Official wording

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Code information: Lot # 37-888736, 37-888769, Exp 05/02/2023; 37-890465, 37-890483, Exp 05/09/2023; 37-892088, 37-892117, 37-892119, 37-892145, Exp 05/16/2023; 37-893759, 37-893765, Exp 05/23/2023; 37-895742, 37-895751, Exp 05/30/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility