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Recall Observatory FDA recall evidence

Drug product

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08

D-0476-2024

April 10, 2024

Class II

Product summary

Firm
Imprimis NJOF, LLC
Event
Event 94378
Status
Ongoing
Classification
Class II
Quantity
3320 bottles
Official record key
drug-enforcement:D-0476-2024

Official wording

Reason: Subpotent Drug

Code information: Lot #: 23JUN031; Exp. 07/03/2024

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent

Field note

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