US Compounding Recalls MIC-Combo Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 1,736 vials of MIC-Combo injection due to deficient practices that may impact 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 classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
US Compounding Inc is recalling 1,736 vials of MIC-Combo, a 30 mL multi-dose vial intended for deep intramuscular injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide.
The recall is being conducted because of deficient practices that may have an impact on the assurance of sterility for these sterile preparations. The affected lots have expiration dates ranging from September 21, 2015, to November 4, 2015.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- MIC-Combo, 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 — Compounded Injectable
- Affected units
- 1,736
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 Code: 20150105@18 BUD: 10/28/2015
- 20150805@34 BUD: 11/4/2015
- 20152603@12 BUD: 9/21/2015
- 20153004@20 BUD: 10/27/2015
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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