Eye Drops Industrial Strength — Class III drug recall D-0322-2015
Terminated recall by K C Pharmaceuticals Inc, reported 2014-12-31, distributed nationwide. CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant
| Recall number | D-0322-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K C Pharmaceuticals Inc, Pomona, CA, United States |
| Recall initiated | 2014-12-04 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 71,904 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00669635240825, 00690689006099 |
| Lot numbers | 01/06, 3A450 |
Product
Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC: 6 69635 24082 5; c) Xpect First aid, Manufactured for Cintas First Aid & Safety, Mason, OH 45040; d) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00609 9.
Reason for recall
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
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-0322-2015. 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.