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.

FDA recall notice · announced August 31, 2016 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point

Notes

Distribution: Nationwide
Lot/code information: Lot#: 1967800, Exp10/2016
Quantity: 4,045 units
Status: Terminated
Products in this recall event:
- 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. (D-1469-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.