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Class III: unlikely to cause harmTerminated

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals Dexamethasone Elixir Recall

DEXAMETHASONE ELIXIR, USP, 0

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals · Huntsville, AL

Risk level
Class III
Reported by FDA
Feb 1, 2017
Recall ID
D-0438-2017
Check your lot numberHow we source this data

Summary

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals recalled Dexamethasone Elixir starting Jan 16, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0438-2017 on Feb 1, 2017. Reason: Failed Impurities/ Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/ Degradation Specifications

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

Lot numbers, UPCs & expiration codes

Lot # 0000007104; Exp 05/17

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0438-2017
Classification
Class III
Status
Terminated
Recall initiated
Jan 16, 2017
FDA report date
Feb 1, 2017
Quantity
2568 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-0438-2017, exactly as published.

Show all FDA fields
City
Huntsville
State
AL
Status
Terminated
Country
United States
Event ID
76272
Address
130 Vintage Dr Ne
Code information
Lot # 0000007104; Exp 05/17
Postal code
35811-8216
Report date
Feb 1, 2017
Product type
Drugs
Recall number
D-0438-2017
Classification
Class III
Recalling firm
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Product quantity
2568 bottles
Termination date
Sep 17, 2017
Reason for recall
Failed Impurities/ Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Jan 16, 2017
Initial firm notification
Letter
Center classification date
Jan 24, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0438-2017, published Feb 1, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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