FDAFDA · Food and drugs·Recall number D-0268-2016
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.
Published November 25, 2015 · Recall initiated: September 12, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- US Compounding Inc
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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