Why it was recalled
Lack of Assurance of Sterility
Product description
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Lot numbers, UPCs & expiration codes
Lot #: QHI 08/19 QJG 10/19 RBA 02/20 RCF 03/20 RCM 03/20 RDJ 04/20 RFA 06/20 RHI 08/20 RJI 10/20 RKG 11/20 SBF 2/21 SDD 04/21
Where it was sold
U.S.A. Nationwide
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-0389-2020
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jul 2, 2019
- FDA report date
- Nov 27, 2019
- Quantity
- 77,760 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Altaire Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0389-2020, exactly as published.
Show all FDA fields
- City
- Aquebogue
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 83265
- Address
- 311 W Ln
- Address (line 2)
- PO Box 849
- Code information
- Lot #: QHI 08/19 QJG 10/19 RBA 02/20 RCF 03/20 RCM 03/20 RDJ 04/20 RFA 06/20 RHI 08/20 RJI 10/20 RKG 11/20 SBF 2/21 SDD 04/21
- Postal code
- 11931-0849
- Report date
- Nov 27, 2019
- Product type
- Drugs
- Recall number
- D-0389-2020
- Classification
- Class II
- Recalling firm
- Altaire Pharmaceuticals, Inc.
- Product quantity
- 77,760 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jul 2, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 15, 2019