FDA Drug recall D-0322-2015
Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter
- FDA Drug
- Class III
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class III recall of Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter by K C Pharmaceuticals, citing CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0322-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-12-04 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | K C Pharmaceuticals |
| Distribution | US |
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
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Identifiers
| upc | 669635240825 |
|---|---|
| upc | 690689006099 |
| code_info | Lot #: 3A450, Expiry: 01/06. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0322-2015%22
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