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Recall Observatory FDA recall evidence

Drug product

Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-35

D-0188-2017

November 18, 2016

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 75745
Status
Terminated
Classification
Class II
Quantity
471 bags
Official record key
drug-enforcement:D-0188-2017

Official wording

Reason: Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Code information: Lot: 9002

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility