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Recall Observatory FDA recall evidence

Drug product

Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.

D-1447-2016

July 07, 2016

Class II

Product summary

Firm
Medicap Pharmacy
Event
Event 74725
Status
Terminated
Classification
Class II
Quantity
1 bottle
Official record key
drug-enforcement:D-1447-2016

Official wording

Reason: Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.

Code information: Lot #: 05092016@19, Beyond Use Date: 06/08/16; Discard After 09/01/2017.

Distribution pattern: ID

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility