D-0152-2017 Class II Terminated
FDA drug recall D-0152-2017 was initiated by Akorn Inc on Nov 14, 2016 and is designated Class II. Reason for recall: Failed Stability Specifications; out-of specification value for homogeneity / phase separation. The recall status is terminated (terminated May 10, 2019). Affected quantity: a) 62 tubes and b) 91 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 30, 2016
- Initiation Date
- Nov 14, 2016
- Termination Date
- May 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 62 tubes and b) 91 tubes
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.
Distribution Pattern
Nationwide
Code Information
Lot #348716 (exp. 12/2017)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0152-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026