Shield and Protect Moisture Barrier Cream recalled over manufacturing violations
- Recall date
- April 19, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Gentell, Inc recalls Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Brist…
- Recall number
- D-0866-2017
- FDA classification
- Class II
- Brand / firm
- Gentell, Inc
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
GMP Deviations; product may not meet cGMP requirements
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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