US Compounding Recalls MIC Combo Vials Due to Sterility Concerns
US Compounding Inc is recalling MIC Combo multi-dose vials because deficient practices may have impacted sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe; while specific injuries are not reported, the lack of sterility assurance in injectable drugs is a significant hazard warranting a Severe rating under the Class II criteria.
Plain-English summary
US Compounding Inc is recalling MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL) 30 mL multi-dose vials. The recall involves 1,939 vials distributed nationwide. The affected lot numbers are 20150705@32, 20151304@17, 20151905@56, and 20152004@9.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for these sterile preparations. The agency has classified this as a Class II recall.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- 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.
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable
- Affected units
- 1,939
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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