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Terminated

Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553

FDA Recall Z-1082-05 · Posted 2005-08-03

Recalling FirmDel Laboratories Inc.
Recall StatusTerminated
Product CodeEFW
Date Initiated2005-06-09
Date Terminated2007-12-11
Product Quantity134,082 units domestically, and 1578 units internationally as samples

Reason for Recall

Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children.

Firm Action

Recall letters were sent on 6/09/05 by FedEx to direct wholesalers/distributors and retailers nationwide. A nationwide press release was issued on 6/10/05, and notification sent to numerous consumer & parenting publications, plus posting on company website. Questions from consumers should be referred to Del Pharmaceuticals at 1-800-818-1915 or by email at [email protected]. Recall letters were sent to 3 direct accounts on 7/21/05 via FedEx after the discovery that these accounts had not been notified.

Root Cause

Other

Distribution Pattern

Nationwide & Puerto Rico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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