FDAFDA · Food and drugs·Recall number 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. 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.
Published December 31, 2014 · Recall initiated: December 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- K C Pharmaceuticals Inc
- Distributor
- U.S. Nationwide and Canada (Ontario).
- Lot
- Lot #: 3A450, Expiry: 01/06.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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