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Recall Observatory FDA recall evidence

Drug product

MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07

D-0265-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
3,629 vials
Official record key
drug-enforcement:D-0265-2016

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: 20150806@41 BUD: 12/5/2015, 20151205@67 BUD: 11/8/2015, 20151504@24 BUD: 10/12/2015, 20152306@30 BUD: 12/20/2015, 20152603@27 BUD: 9/22/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility