# FDA recall D-0898-2023

> **K.C. Pharmaceuticals, Inc** · Class II · drug recall initiated 2023-06-13.

## 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.

## Reason for recall

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0898-2023
- **Recalling firm:** K.C. Pharmaceuticals, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-06-13
- **Report date:** 2023-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pomona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0898-2023

## Citation

> AI Analytics. FDA recall D-0898-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0898-2023. Source: US FDA. Licensed CC0.

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