Why it was recalled
Non-Sterility
Product description
CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0294-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Nov 13, 2023
- FDA report date
- Feb 14, 2024
- Quantity
- 110,832 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kilitch Healthcare India Limited
Original FDA data
Every field from FDA enforcement report D-0294-2024, exactly as published.
Show all FDA fields
- City
- Navi Mumbai
- Status
- Ongoing
- Country
- India
- Event ID
- 93357
- Address
- R - 904 905 T T C Industrial Road
- Code information
- All lots
- Report date
- Feb 14, 2024
- Product type
- Drugs
- Recall number
- D-0294-2024
- Classification
- Class I
- Recalling firm
- Kilitch Healthcare India Limited
- Product quantity
- 110,832 bottles
- Reason for recall
- Non-Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 13, 2023
- Initial firm notification
- Press Release
- Center classification date
- Feb 5, 2024