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Dong-A Pharmaceutical Co., Ltd.
Dong-A Pharmaceutical Co., Ltd. · Model Tempo Natural Tampon Regular · UDI-DI 08806011635697
10
510(k) clearances
11,919
Adverse events (13 deaths)
36
Recalls
95
Facilities
Description
The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-26 | GOLD STAR DISTRIBUTION INC | Potential exposure of rodents and rodent activity in the distribution center. |
| 2025-02-17 | DAYE (ANNE'S DAY LTD) | Product lacks 510(k) clearance. |
| 2025-02-17 | DAYE (ANNE'S DAY LTD) | Product lacks 510(k) clearance. |
| 2025-02-17 | DAYE (ANNE'S DAY LTD) | Product lacks 510(k) clearance. |
| 2025-02-17 | DAYE (ANNE'S DAY LTD) | Product lacks 510(k) clearance. |
| 2025-02-17 | DAYE (ANNE'S DAY LTD) | Product lacks 510(k) clearance. |
| 2025-02-17 | DAYE (ANNE'S DAY LTD) | Product lacks 510(k) clearance. |
| 2025-02-17 | DAYE (ANNE'S DAY LTD) | Product lacks 510(k) clearance. |
| 2025-02-17 | DAYE (ANNE'S DAY LTD) | Product lacks 510(k) clearance. |
| 2025-02-17 | DAYE (ANNE'S DAY LTD) | Product lacks 510(k) clearance. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.