FDA Recall D-0898-2023

K.C. Pharmaceuticals, Inc · Pomona, CA

Class II Ongoing 1066 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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

Quantity: 397,430 bottles

Reason for recall

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

Recall record

Recall number: D-0898-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the USA
Recall initiated: 2023-06-13
Classified by FDA Center: 2023-07-07
FDA published: 2023-07-19
Recalling firm: K.C. Pharmaceuticals, Inc
Firm location: Pomona, CA

Drug identification

Brand name(s): EQUATE EYE DROPS DRY EYE RELIEF, SUNMARK EYE DROPS ORIGINAL FORMULA, MEIJER DRY EYE RELIEF, ARTIFICIAL TEARS
Generic name(s): GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, GLYCERIN
Manufacturer(s): Wal-Mart Stores, Inc., Strategic Sourcing Services LLC, Meijer Distribution, Inc., Geri-Care Pharmaceuticals, Corp
NDC(s): 49035-280, 49348-037, 41250-718, 57896-181
Route(s): OPHTHALMIC

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls