Recalls / Class III

Class IIID-0438-2017

Product

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

Affected lot / code info

Lot # 0000007104; Exp 05/17

Why it was recalled

Failed Impurities/ Degradation Specifications

Recalling firm

Firm

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

130 Vintage Dr Ne, N/A, Huntsville, Alabama 35811-8216

Distribution

Quantity

2568 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2017-01-16

FDA classified

2017-01-24

Posted by FDA

2017-02-01

Terminated

2017-09-17

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0438-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.