Drug recall
Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ…
FDA recall event 92533 · Class II · K.C. Pharmaceuticals, Inc
Key facts
| Event ID | 92533 |
|---|---|
| Recall numbers | D-0897-2023, D-0898-2023 |
| Recalling firm | K.C. Pharmaceuticals, Inc |
| Product type | Drugs |
| Products | 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…, Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. |
| Initiation date | Jun 13, 2023 |
| Report date | Jul 19, 2023 |
| City | Pomona |
| State | CA |
| Country | United States |
| FEI number | 2026940 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: