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Recall Observatory FDA recall evidence

Drug product

Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02

D-0255-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
5,118 syringes
Official record key
drug-enforcement:D-0255-2016

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: 20150906@32 BUD: 12/6/2015, 20150906@33 BUD: 12/6/2015, 20151105@45 BUD: 11/7/2015, 20151205@12 BUD: 11/8/2015, 20151404@39 BUD: 10/11/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility