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Recall Observatory FDA recall evidence

Drug product

Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

D-0239-2019

October 18, 2018

Class III

Product summary

Firm
Promise Pharmacy LLC
Event
Event 81351
Status
Terminated
Classification
Class III
Quantity
N/A
Official record key
drug-enforcement:D-0239-2019

Official wording

Reason: Presence of precipitate

Code information: Lot#: 04092018@2, Exp 12/03/2018

Distribution pattern: U.S.A. Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Presence of precipitate