Recalls / Class III
Class IIID-0333-2015
Product
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
- Affected lot / code info
- Lots 1413900, 1417200, 1417300, Exp. 02/15
Why it was recalled
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W. Field Court, Suite 300, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 3,937 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-09
- FDA classified
- 2015-01-06
- Posted by FDA
- 2015-01-14
- Terminated
- 2017-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0333-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.