PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: February 1, 2017 Initiated: January 16, 2017 #D-0438-2017

Product Description

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

Reason for Recall

Failed Impurities/ Degradation Specifications

Details

Units Affected
2568 bottles
Distribution
Nationwide
Location
Huntsville, AL

Frequently Asked Questions

What product was recalled?
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56. Recalled by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals. Units affected: 2568 bottles.
Why was this product recalled?
Failed Impurities/ Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 1, 2017. Severity: Low. Recall number: D-0438-2017.