Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Ak...

FDA Drug Recall #D-050-2013 — Class III — June 18, 2012

Recall Summary

Recall Number D-050-2013
Classification Class III — Low risk
Date Initiated June 18, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stat Rx USA
Location Gainesville, GA
Product Type Drugs
Quantity 22 units

Product Description

Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,

Reason for Recall

Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."

Distribution Pattern

FL, PA, and VA.

Lot / Code Information

Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14

Other Recalls from Stat Rx USA

Recall # Classification Product Date
D-144-2013 Class III Methocarbamol 750 mg Tablets, 90-count bottle, ... Jan 28, 2013
D-051-2013 Class III Venlafaxine ER 150mg, 30 Tabs bottle, Generic f... Aug 23, 2012
D-1427-2012 Class III Tizanidine (Generic for: Zanaflex), 4 mg, 90 Ta... Jul 23, 2012

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.