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Recall Observatory FDA recall evidence

Drug product

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676223

D-0116-2020

September 12, 2019

Class II

Product summary

Firm
KRS Global Biotechnology, Inc
Event
Event 83789
Status
Terminated
Classification
Class II
Quantity
242 droptainers
Official record key
drug-enforcement:D-0116-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility