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Recall Observatory FDA recall evidence

Drug product

C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0003-2020

July 24, 2019

Class II

Product summary

Firm
Colonia Care Pharmacy
Event
Event 83427
Status
Terminated
Classification
Class II
Quantity
2 droptainer bottles
Official record key
drug-enforcement:D-0003-2020

Official wording

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

Code information: Lot #: a) 070819A, BUD 08/22/19; b) 071619F, BUD 08/30/19

Distribution pattern: Patient Specific Prescriptions in NJ

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility