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Recall Observatory FDA recall evidence

Drug product

MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.

D-0268-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
1,939 vials
Official record key
drug-enforcement:D-0268-2016

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: 20150705@32 BUD: 11/2/2015, 20151304@17 BUD: 10/10/2015, 20151905@56 BUD: 11/15/2015, 20152004@9 BUD: 10/17/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility