Skip to content
Recall Observatory FDA recall evidence

Drug product

Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02

D-0248-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
4,333 vials
Official record key
drug-enforcement:D-0248-2016

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: 20150107@23 BUD: 12/28/2015; 20151305@43 BUD: 11/9/2015; 20151307@18 BUD: 1/9/2016; 20152204@33 BUD: 10/19/2015; 20152606@1 BUD: 12/22/2015; 20153003@34 BUD: 9/26/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility