Recalls / Class I
Class ID-0305-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15
- Affected lot / code info
- All lots
Why it was recalled
Non-Sterility
Recalling firm
- Firm
- Kilitch Healthcare India Limited
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- R - 904 905 T T C Industrial Road, Navi Mumbai, N/A, India
Distribution
- Quantity
- 45,408 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-11-13
- FDA classified
- 2024-02-05
- Posted by FDA
- 2024-02-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0305-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.