Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allent...

FDA Drug Recall #D-0794-2016 — Class II — February 12, 2016

Recall Summary

Recall Number D-0794-2016
Classification Class II — Moderate risk
Date Initiated February 12, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Walter's Pharmacy
Location Allentown, PA
Product Type Drugs
Quantity 2 bottles

Product Description

Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

PA

Lot / Code Information

Lot #: 012116, 012516

Other Recalls from Walter's Pharmacy

Recall # Classification Product Date
D-0798-2016 Class II Tobramycin 14 mg/mL Ophth Solution, 10mL bottle... Feb 12, 2016
D-0796-2016 Class II Lidocaine Nebulizer 1% Solution, Rx only, Walte... Feb 12, 2016
D-0797-2016 Class II Vancomycin 50mg/mL Solution, 10mL bottle, Rx on... Feb 12, 2016
D-0786-2016 Class II Cefazolin 50 mg/mL Ophth Solution, 10mL bottle,... Feb 12, 2016
D-0789-2016 Class II Rose Bengal 1% Ophth Solution, 5mL bottle, Rx o... Feb 12, 2016

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.