Skip to content
Recall Observatory FDA recall evidence

Drug product

HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25

D-0948-2018

June 12, 2018

Class II

Product summary

Firm
Avella of Deer Valley, Inc. Store 38
Event
Event 80307
Status
Terminated
Classification
Class II
Quantity
40 bags
Official record key
drug-enforcement:D-0948-2018

Official wording

Reason: Lack of Assurance of Sterility: Potential leakage of bags.

Code information: Lot #: 5/1/18 0511 515-74725P, BUD 7/30/2018.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility