Rohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Men
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Product
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
- Reason / hazard
- Lack of Assurance of Sterility
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2026-07-14
- Code info
- Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06; 512V, 512VB 2028/08
- Product quantity
- 353 cartons
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Ho Chi Minh
- State
- N/A
- Country
- Vietnam
- Event id
- 99440
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