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Class III: unlikely to cause harmTerminated

Akorn Triamcinolone Acetonide Lotion Recall

Triamcinolone Acetonide Lotion USP, 0

Akorn, Inc. · Lake Forest, IL

Risk level
Class III
Reported by FDA
Jan 14, 2015
Recall ID
D-0333-2015
Check your lot numberHow we source this data

Summary

Akorn recalled Triamcinolone Acetonide Lotion starting Dec 9, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0333-2015 on Jan 14, 2015. Reason: Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

Product description

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).

Lot numbers, UPCs & expiration codes

Lots 1413900, 1417200, 1417300, Exp. 02/15

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-0333-2015
Classification
Class III
Status
Terminated
Recall initiated
Dec 9, 2014
FDA report date
Jan 14, 2015
Quantity
3,937 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0333-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
70041
Address
1925 W. Field Court, Suite 300
Code information
Lots 1413900, 1417200, 1417300, Exp. 02/15
Postal code
60045
Report date
Jan 14, 2015
Product type
Drugs
Recall number
D-0333-2015
Classification
Class III
Recalling firm
Akorn, Inc.
Product quantity
3,937 bottles
Termination date
Jan 26, 2017
Reason for recall
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Distribution pattern
Nationwide
Recall initiation date
Dec 9, 2014
Initial firm notification
Letter
Center classification date
Jan 6, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0333-2015, published Jan 14, 2015. 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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