Recalls / Class III
Class IIID-1469-2016
Product
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
- Affected lot / code info
- Lot#: 1967800, Exp10/2016
Why it was recalled
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 4,045 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-07-27
- FDA classified
- 2016-08-24
- Posted by FDA
- 2016-08-31
- Terminated
- 2017-07-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1469-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.