Skip to content
Recall Observatory FDA recall evidence

Drug product

Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07

D-0245-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
1,198 bottles
Official record key
drug-enforcement:D-0245-2016

Official wording

Reason: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information: Lot Numbers: 20152707@22 BUD: 10/25/2015; 20150707@9 BUD: 10/5/2015; 20152906@15 BUD: 9/27/2015; 20152907@2 BUD: 10/27/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility