RecallRadar

FDA Drug recall D-0866-2017

Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232…

On 2017-05-31 the FDA classified a Class II recall of Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232… by Gentell, citing GMP Deviations; product may not meet cGMP requirements.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0866-2017
ClassificationClass II
Statusterminated
Initiated2017-04-19
Published2017-05-31
Last updated2026-09-13 11:51 UTC
CompanyGentell
DistributionUS

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

GMP Deviations; product may not meet cGMP requirements

Identifiers

code_infoProduct Code GEN-23240

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0866-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.