Eye Drops advanced relief — Class II drug recall D-192-2013
Terminated recall by K C Pharmaceuticals Inc, reported 2013-03-20, distributed nationwide. Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front
| Recall number | D-192-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K C Pharmaceuticals Inc, Pomona, CA, United States |
| Recall initiated | 2010-03-01 |
| Classified | 2013-03-08 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 31,704 bottles |
| Reason classes | labeling |
| Lot numbers | 12/12, 9P367 |
Product
Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072.
Reason for recall
Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-192-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.