D-0866-2017 Class II Terminated
FDA drug recall D-0866-2017 was initiated by Gentell, Inc on Apr 19, 2017 and is designated Class II. Reason for recall: GMP Deviations; product may not meet cGMP requirements The recall status is terminated (terminated Feb 16, 2018). Affected quantity: 65 gallons.
Recall details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- Apr 19, 2017
- Termination Date
- Feb 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 gallons
Product description
Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
Reason for recall
GMP Deviations; product may not meet cGMP requirements
Distribution pattern
Nationwide and Puerto Rico
Code information
Product Code GEN-23240
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0866-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026