Skip to content
Recall Observatory FDA recall evidence

Drug product

heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8100-1.

D-0746-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
2992 bags
Official record key
drug-enforcement:D-0746-2023

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 # 37-888833, Exp 05/02/2023; 37-890537, Exp 05/09/2023; 37-892161, 37-892163, Exp 05/16/2023; 37-893979, 37-893992, Exp 05/23/2023; 37-895755, 37-895758, 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