US Compounding Recalls Trace Elements-4 IV Vials Due to Sterility Concerns
US Compounding Inc is recalling 1,093 vials of Trace Elements-4 IV injection due to deficient practices that may impact 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an IV injection product, which poses a significant risk of serious injury or infection.
Plain-English summary
US Compounding Inc is recalling 1,093 vials of Trace Elements-4, a 10 mL multi-dose vial intended for IV injection after dilution. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide. The recall is initiated due to deficient practices that may have an impact on sterility assurance for sterile preparations within their expiry dates.
The affected lots include Lot Code 20152804@35 with a beyond-use date of 10/25/2015, and Lot Code 20150505@26 with a beyond-use date of 11/1/2015. The product is prescription-only and contains Zinc Sulfate heptahydrate, Cupric Sulfate pentahydrate, Manganese Sulfate monohydrate USP, and Chromic Chloride hexahydrate USP.
Healthcare providers and patients should discontinue use of the affected vials and contact US Compounding Inc for further instructions or returns. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by
- Manufacturer
- US Compounding Inc
- Category
- Drug — IV Injection
- Affected units
- 1,093
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 (2)
- Lot Code: 20152804@35 BUD: 10/25/2015
- 20150505@26 BUD: 11/1/2015
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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