# FDA recall D-0322-2015

> **K C Pharmaceuticals Inc** · Class III · drug recall initiated 2014-12-04.

## 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.

## Distribution

U.S. Nationwide and Canada (Ontario).

## Key facts

- **Recall number:** D-0322-2015
- **Recalling firm:** K C Pharmaceuticals Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-04
- **Report date:** 2014-12-31
- **Termination date:** 2015-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pomona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0322-2015

## Citation

> AI Analytics. FDA recall D-0322-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0322-2015. Source: US FDA. Licensed CC0.

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