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Recall Observatory FDA recall evidence

Drug product

Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979

D-1578-2019

July 17, 2019

Class II

Product summary

Firm
ImprimisRx NJ
Event
Event 83353
Status
Terminated
Classification
Class II
Quantity
405 bottles
Official record key
drug-enforcement:D-1578-2019

Official wording

Reason: Subpotent Drug

Code information: Lot #:01252019@1, Exp. 07/21/2019; 03182019@7, Exp. 09/7/2019; 05092019@2, Exp. 11/2/2019

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent