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
Reported: November 30, 2016 Initiated: November 14, 2016 #D-0152-2017
Product Description
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
Reason for Recall
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- a) 62 tubes and b) 91 tubes
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn Inc. Units affected: a) 62 tubes and b) 91 tubes.
Why was this product recalled? ▼
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 30, 2016. Severity: Moderate. Recall number: D-0152-2017.
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