Recalls / Class II
Class IID-0152-2017
Product
Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
- Affected lot / code info
- Lot #348716 (exp. 12/2017)
Why it was recalled
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- a) 62 tubes and b) 91 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-14
- FDA classified
- 2016-11-23
- Posted by FDA
- 2016-11-30
- Terminated
- 2019-05-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0152-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.