Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-10-04 | Z-0266-2024 | Class II | Open, Classified | Products were stored outside of labeled temperature requirements.Distribution: Distributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA. | 329,044 total units | clearance family |
| 2022-06-23 | Z-1537-2022 | Class II | Open, Classified | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.Distribution: Product distributed to Family Dollar retail stores in US nationwide. | 77 | clearance family |
Regulatory clearances
- 510(k)K123436Substantially equivalent (SESE) · 2013-08-26clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-12 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2024-07-18 | NAI | No action indicated | Church & Dwight Canada Corp. | 0 |
| 2023-08-08 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2022-07-15 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2020-08-14 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2020-08-14 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2017-10-31 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 1 |
| 2015-08-06 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2015-08-06 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2015-03-13 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 2 |
| 2012-08-24 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 2 |
| 2012-02-13 | VAI | Voluntary action indicated | Church & Dwight Inc | 5 |
| 2012-02-13 | VAI | Voluntary action indicated | Church & Dwight Inc | 5 |
| 2011-05-16 | WL | Warning Letter | Church & Dwight Inc | — |
| 2011-05-16 | WL | Warning Letter | Church & Dwight Inc | — |
| 2011-02-17 | NAI | No action indicated | Church & Dwight Co., Inc. | 0 |
| 2011-02-17 | OAI | Official action indicated | Church & Dwight Inc | 7 |
| 2011-02-17 | OAI | Official action indicated | Church & Dwight Inc | 7 |
| 2010-07-08 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 3 |
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