Recalls / Class II
Class IID-0898-2023
Product
Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL) Bottles, 1 FL OZ (30 mL) TOTAL, UPC 6 81131 36701 1, NDC 49035-280-02; b) DG health, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; c) sunmark, Distributed By McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 62144 3, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; e) HealthMart, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 52569 13715 4; f) exchange select Artificial Tears, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; g) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, UPC 7 13733 29692 2, NDC 41250-718-01; h) H.E.B, MADE WITH PRIDE AND CARE FOR H.E.B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; i) GeriCare, Distributed by: Gericare Pharmaceuticals Corp., 1650 63rd St., Brooklyn, NY 11204, UPC 3 57896 18405 6, NDC 57896-181-05
- Brand names
- Equate Eye Drops Dry Eye Relief, Sunmark Eye Drops Original Formula, Meijer Dry Eye Relief, Artificial Tears
- Generic names
- Glycerin, Hypromellose, Polyethylene Glycol 400, Tetrahydrozoline Hcl, Glycerin
- Active ingredients
- Glycerin, Hypromellose, Unspecified, Polyethylene Glycol 400, Tetrahydrozoline Hydrochloride, Hypromelloses
- Route
- Ophthalmic
- NDCs
- 49035-280, 49348-037, 41250-718, 57896-181
- FDA application
- M018
- Affected lot / code info
- Lot #: a) LT21FO2, LT21F03, Exp 6/2023; b) LT21FO2, LT21F03, Exp 6/2023; c) LT21FO2, LT21F03, Exp 6/2023; d) LT21FO2, LT21F03, Exp 6/2023; e) LT21F02, Exp 6/2023; f) LT21F02, Exp 6/2023; g) LT21F03, Exp 6/2023; h) LT21F03, Exp 6/2023; i) LT21F03, Exp 6/2023
Why it was recalled
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Recalling firm
- Firm
- K.C. Pharmaceuticals, Inc
- Manufacturer
- Wal-Mart Stores, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 3215 Producer Way, N/A, Pomona, California 91768-3916
Distribution
- Quantity
- 397,430 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-06-13
- FDA classified
- 2023-07-07
- Posted by FDA
- 2023-07-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0898-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.