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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

Drug Recall

Official source record

Recall number
D-0898-2023
Event ID
92533
Classification
Class II
Status
Ongoing
Recalling company
K.C. Pharmaceuticals, Inc
Reason for recall
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Report date
July 19, 2023
Recall initiation date
June 13, 2023
Termination date
Not terminated as of this source record
Distribution pattern
Nationwide in the USA

Drug product identifiers

Manufacturer
Geri-Care Pharmaceuticals, Corp; Meijer Distribution, Inc.; Strategic Sourcing Services LLC; Wal-Mart Stores, Inc.
Brand names
ARTIFICIAL TEARS; EQUATE EYE DROPS DRY EYE RELIEF; MEIJER DRY EYE RELIEF; SUNMARK EYE DROPS ORIGINAL FORMULA
Generic names
GLYCERIN; GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HCL
Substance names
GLYCERIN; HYPROMELLOSE, UNSPECIFIED; HYPROMELLOSES; POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE
Product NDCs
41250-718; 49035-280; 49348-037; 57896-181
Package NDCs
41250-718-01; 49035-280-01; 49035-280-02; 49348-037-29; 57896-181-05
Route
OPHTHALMIC

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to the FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this medication?

Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.

Where can I find more official information?

The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.