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Recall Observatory FDA recall evidence

Drug product

Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05

D-0271-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
15,640 syringes
Official record key
drug-enforcement:D-0271-2016

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 Code: 20150106@48 BUD: 11/28/2015, 20150106@49 BUD: 11/28/2015, 20150306@37 BUD: 11/30/2015, 20150906@50 BUD: 12/6/2015, 20150906@7 BUD: 12/5/2015, 20151208@32 BUD: 2/8/2016, 20152304@2 BUD: 10/20/2015, 20152804@6 BUD:10/24/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility