Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozo...

FDA Drug Recall #D-192-2013 - Class II, March 1, 2010

Recall Summary

Recall Number D-192-2013
Classification Class II - Moderate risk
Date Initiated March 1, 2010
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm K C Pharmaceuticals Inc
Location Pomona, CA
Product Type Drugs
Quantity 31,704 bottles

Product 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.

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.

Distribution Pattern

Nationwide

Lot / Code Information

Lot #: 9P367, Exp 12/12

Other Recalls from K C Pharmaceuticals Inc

Recall # Classification Product Date
D-0321-2015 Class III Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zin... Dec 4, 2014
D-0323-2015 Class III Eye Drops Advanced Relief (Dextran 70 0.1%, Pol... Dec 4, 2014
D-0320-2015 Class III Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL ... Dec 4, 2014
D-0322-2015 Class III Eye Drops Industrial Strength (Polyethylene gly... Dec 4, 2014

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.