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.
Reported: August 31, 2016 Initiated: July 27, 2016 #D-1469-2016
Product Description
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
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 4,045 units
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akorn, Inc.. Units affected: 4,045 units.
Why was this product recalled? ▼
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 31, 2016. Severity: Low. Recall number: D-1469-2016.
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