Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%),...
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good Neighbor Pharmacy Eye Drops, Redness & Dry Eye Relief, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-606-05; c) Colirio Ojo De Aguila Eye Drops, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01615 5; d) Colirio OFTAL-MYCIN, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01613 1; e) LEADER Redness Relief, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; f) Equaline, sterile redness relief, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 46151 2; g) Walgreens, Redness Relief Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Foster & Thrive, Redness Relief Eye Drops, Sterile, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1161-1; i) LUBRICANT EYE DROPS, Redness Relief, DISTRIBUTEDBY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011, NDC 11822-6453-4; j) Discount drug mart, Eye Drops Redness Relief, Distributed by: Discount Drug Mart, Medina, OH 44256, UPC 0 93351 03411 4
Additional Source Details
| Field | Value |
|---|---|
| City | Pomona |
| State | CA |
| Openfda › Nui › 1 | N0000185370 |
| Openfda › Nui › 2 | N0000175629 |
| Openfda › Nui › 3 | N0000184306 |
| Openfda › Nui › 4 | N0000185001 |
| Openfda › Nui › 5 | M0000728 |
| Openfda › Nui › 6 | M0009417 |
| Openfda › Upc › 1 | 0096295137620 |
| Openfda › Upc › 2 | 0096295137637 |
| Openfda › Upc › 3 | 0010939958310 |
| Openfda › Upc › 4 | 348201016155 |
| Openfda › Upc › 5 | 348201016131 |
| Openfda › Upc › 6 | 041163461512 |
| Openfda › Upc › 7 | 311917177410 |
| Openfda › Upc › 8 | 093351034114 |
| Openfda › Unii › 1 | PDC6A3C0OX |
| Openfda › Unii › 2 | MZ1131787D |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 1046700 |
| Openfda › Spl id › 1 | 546a55db-3cbf-9962-e063-6294a90aebd9 |
| Openfda › Spl id › 2 | 4c91a663-6346-f40f-e063-6294a90a2553 |
| Openfda › Spl id › 3 | 47492a43-35f4-5c2c-e063-6394a90a5b7f |
| Openfda › Brand name › 1 | GNP EYE DROPS REDNESS AND DRY EYE RELIEF |
| Openfda › Brand name › 2 | LEADER EYE DROPS REDNESS RELIEF |
| Openfda › Brand name › 3 | FOSTER AND THRIVE REDNESS RELIEF EYE DROPS |
| Openfda › Spl set id › 1 | 9b5c8b83-36c5-765b-e053-2995a90a395c |
| Openfda › Spl set id › 2 | aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a |
| Openfda › Spl set id › 3 | 0042e9a0-9693-d7e0-e063-6294a90ae6c6 |
| Openfda › Package ndc › 1 | 46122-606-05 |
| Openfda › Package ndc › 2 | 70000-0010-1 |
| Openfda › Package ndc › 3 | 70000-0010-2 |
| Openfda › Package ndc › 4 | 70677-1161-1 |
| Openfda › Package ndc › 5 | 11822-6453-4 |
| Openfda › Product ndc › 1 | 46122-606 |
| Openfda › Product ndc › 2 | 70000-0010 |
| Openfda › Product ndc › 3 | 70677-1161 |
| Openfda › Generic name › 1 | GLYCERIN, NAPHAZOLINE HCL |
| Openfda › Generic name › 2 | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class cs › 1 | Allergens [CS] |
| Openfda › Pharm class cs › 2 | Glycerol [CS] |
| Openfda › Pharm class pe › 1 | Increased Histamine Release [PE] |
| Openfda › Pharm class pe › 2 | Cell-mediated Immunity [PE] |
| Openfda › Pharm class pe › 3 | Increased IgG Production [PE] |
| Openfda › Substance name › 1 | GLYCERIN |
| Openfda › Substance name › 2 | NAPHAZOLINE HYDROCHLORIDE |
| Openfda › Pharm class epc | Non-Standardized Chemical Allergen [EPC] |
| Openfda › Manufacturer name › 1 | AmerisourceBergen |
| Openfda › Manufacturer name › 2 | Cardinal Health |
| Openfda › Manufacturer name › 3 | Strategic Sourcing Services LLC |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98533 |
| Address 1 | 3420 Pomona Blvd |
| Code info | Lot: a) RL24D01, Exp.: 04/30/26; RL24F01, RL24F02, Exp.:06/30/26; b) RL24F01, RL24F02, Exp.:06/30/26; c) RL24F01, Exp.:06/30/26; d) RL24F02, Exp.:06/30/26; e) RL24F01, RL24F02, Exp.:06/30/26; f) RL24F01, RL24F02, Exp.:06/30/26; g) RL24F01, RL24F02, Exp.:06/30/26; h) RL24F01, Exp.:06/30/26; i) RL24F01, Exp.:06/30/26; j) RL24F02, Exp.:06/30/26; k) |
| Postal code | 91768-3236 |
| Report date | 20260408 |
| Product type | Drugs |
| Product quantity | 315,144 bottles |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260303 |
| Initial firm notification | |
| Center classification date | 20260331 |
Overview
- Recalling FirmK.C. Pharmaceuticals, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the US