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Recall Observatory FDA recall evidence

Drug product

Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35

D-0016-2017

September 20, 2016

Class II

Product summary

Firm
Leiter's Compounding
Event
Event 75230
Status
Terminated
Classification
Class II
Quantity
76,315 total units, all products
Official record key
drug-enforcement:D-0016-2017

Official wording

Reason: Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Code information: All unexpired lots; Expirations dates of 09/21/2016 to 2/2/2017

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility