🔍 RecallPedia

Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072.

Class I - Dangerous
💊 Drugs Recalled: March 1, 2010 K C Pharmaceuticals Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 9P367, Exp 12/12
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
K C Pharmaceuticals Inc
Reason for Recall:
Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072.

Product Codes/Lot Numbers:

Lot #: 9P367, Exp 12/12

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-192-2013

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K C Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Dec 4, 2014 Over-the-Counter Nationwide View Details →

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K C Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Dec 4, 2014 Over-the-Counter Nationwide View Details →

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K C Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Dec 4, 2014 Over-the-Counter Nationwide View Details →