Recall Z-1082-05 ยท EFW Toothbrush, Manual
Del Laboratories Inc.
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
| Date | Aug 3, 2005 (initiated Jun 9, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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 consumer_relations@orajel.com. Recall letters were sent to 3 direct accounts on 7/21/05 via FedEx after the discovery that these accounts had not been notified. |
| Quantity | 134,082 units domestically, and 1578 units internationally as samples |
| Distribution | Nationwide & Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.