PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
FDA Drug Recall #D-474-2013 — Class II — April 22, 2013
Recall Summary
| Recall Number | D-474-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 22, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nora Apothecary and Alternative Therapies, Inc. |
| Location | Indianapolis, IN |
| Product Type | Drugs |
| Quantity | 2 |
Product Description
PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Distribution Pattern
Nationwide
Lot / Code Information
All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Other Recalls from Nora Apothecary and Alternative Thera...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-489-2013 | Class II | Renacidin Irrigation: 1000 ml,1120ml Bladder ... | Apr 22, 2013 |
| D-456-2013 | Class II | Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x... | Apr 22, 2013 |
| D-471-2013 | Class II | Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic So... | Apr 22, 2013 |
| D-463-2013 | Class II | Trimix Inj 30:1:40 MDV, 5 ml Penile Injection,... | Apr 22, 2013 |
| D-464-2013 | Class II | Trimix Inj 30:3:5 MDV, 10ml Penile Injection, ... | Apr 22, 2013 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
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.