FDAClass IINovember 25, 2015

Trace Elements-4 recall: Sterility Concern

Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride…

Why was Trace Elements-4 recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: 20152804@35 BUD: 10/25/2015, 20150505@26 BUD: 11/1/2015

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…
Recalling firm
US Compounding Inc
Quantity
1,093 vials
Distribution
Nationwide
Recall date
November 25, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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