Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed…
Reason Lack of Assurance of Sterility
Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility
What was recalled
Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1
- Recalling firm
- Kilitch Healthcare India Limited
- NDC code
- 70000-0587-1
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0301-2024
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Propylene recalls
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Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER…
Reason Lack of Assurance of Sterility
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