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Recall Observatory FDA recall evidence

Drug product

Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-236-03

D-1076-2017

July 14, 2017

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 77780
Status
Terminated
Classification
Class II
Quantity
6210 syringes
Official record key
drug-enforcement:D-1076-2017

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: 9814, 9831 BUD: 9/12/2017; 10059, BUD: 10/18/2017

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility