Class II · Moderate risk
Artificial Tears Sterile Lubricant Eye Drops
Lack of Assurance of Sterility
Dry Eye Relief Lubricant Eye Drops
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDCs
41250-0718-01
49035-0280-02
49348-0037-29
57896-0181-05
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Meijer Dry Eye Relief Glycerin, Hypromellose, Polyethylene glycol 400 NDC 41250-0718 |
GLYCERIN .2 g/100mL; POLYETHYLENE GLYCOL 400 1 g/100mL; HYPROMELLOSE, UNSPECIFIED .2 g/100mL | Solution/ Drops Ophthalmic |
Meijer Distribution, Inc. | OTC |
| Equate Eye Drops Dry Eye Relief Glycerin, Hypromellose, Polyethylene Glycol 400 NDC 49035-0280 |
GLYCERIN .2 g/100mL; HYPROMELLOSE, UNSPECIFIED .2 g/100mL; POLYETHYLENE GLYCOL 400 1 g/100mL | Solution/ Drops Ophthalmic |
Wal-Mart Stores, Inc. | OTC |
| Sunmark Eye Drops Original Formula Tetrahydrozoline HCl NDC 49348-0037 |
TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL | Solution/ Drops Ophthalmic |
Strategic Sourcing Services LLC | OTC |
| Artificial Tears Glycerin NDC 57896-0181 |
.002 mg/mg; HYPROMELLOSES .002 mg/mg; POLYETHYLENE GLYCOL 400 .01 mg/mg | Solution/ Drops Ophthalmic |
Geri-Care Pharmaceuticals, Corp | OTC |
- Recalling firm
- K.C. Pharmaceuticals, Inc
- NDC code
- 49035-280-02
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0898-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by K.C. Pharmaceuticals, Inc
All 2023 recalls
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