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Dong-A Pharmaceutical Co., Ltd.
Dong-A Pharmaceutical Co., Ltd. · Model Tempo Tampon Regular · UDI-DI 08806011632863
10
510(k) clearances
11,966
Adverse events (13 deaths)
36
Recalls
97
Facilities
Description
The Tempo 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.