Shield and Protect Moisture Barrier Cream — Class II drug recall D-0866-2017
Terminated recall by Gentell, Inc, reported 2017-05-31, distributed nationwide. GMP Deviations; product may not meet cGMP requirements
| Recall number | D-0866-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentell, Inc, Bristol, PA, United States |
| Recall initiated | 2017-04-19 |
| Classified | 2017-05-24 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2018-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 65 gallons |
| Reason classes | cgmp |
| NDC | 61554-0232-40 |
Product
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.