Why it was recalled
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 3A450, Expiry: 01/06.
Where it was sold
U.S. Nationwide and Canada (Ontario).
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0322-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 4, 2014
- FDA report date
- Dec 31, 2014
- Quantity
- 71904 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- K C Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0322-2015, exactly as published.
Show all FDA fields
- City
- Pomona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 69945
- Address
- 3201 Producer Way
- Code information
- Lot #: 3A450, Expiry: 01/06.
- Postal code
- 91768-3916
- Report date
- Dec 31, 2014
- Product type
- Drugs
- Recall number
- D-0322-2015
- Classification
- Class III
- Recalling firm
- K C Pharmaceuticals Inc
- Product quantity
- 71904 Bottles
- Termination date
- Oct 26, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide and Canada (Ontario).
- Recall initiation date
- Dec 4, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2014