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Recall Observatory FDA recall evidence

Drug product

Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37

D-0184-2017

November 18, 2016

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 75745
Status
Terminated
Classification
Class II
Quantity
80 bags
Official record key
drug-enforcement:D-0184-2017

Official wording

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

Code information: Lot: 169170

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility