Agency classClass IIOur severity:Severe FDA (Drugs)·D-0268-2016·Announced 2015-11-25

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: sterility
infection
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.

See all 59 products in this recall →

Same manufacturer · US Compounding Inc

See all →

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Same hazard · sterility