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Recall Observatory FDA recall evidence

Drug product

C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0014-2020

July 24, 2019

Class II

Product summary

Firm
Colonia Care Pharmacy
Event
Event 83427
Status
Terminated
Classification
Class II
Quantity
18 vials
Official record key
drug-enforcement:D-0014-2020

Official wording

Reason: Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Code information: Lot #: 041119A, BUD 10/08/19; 051019J, BUD 11/6/19; 070519C, BUD 01/01/20

Distribution pattern: Patient Specific Prescriptions in NJ

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility