FDAClass IIIFebruary 1, 2017

Dexamethasone Elixir recall: Impurity Out of Spec

DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56

Why was Dexamethasone Elixir recalled?

Failed Impurities/ Degradation Specifications

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 # 0000007104; Exp 05/17

Product
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Recalling firm
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Quantity
2568 bottles
Distribution
Nationwide
Recall date
February 1, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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