Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding P...

FDA Drug Recall #D-1040-2013 — Class II — August 26, 2013

Recall Summary

Recall Number D-1040-2013
Classification Class II — Moderate risk
Date Initiated August 26, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Leiter's Pharmacy
Location San Jose, CA
Product Type Drugs
Quantity 265 vials

Product Description

Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

Reason for Recall

Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.

Distribution Pattern

Nationwide

Lot / Code Information

Lot #: 08052013@1, 08052013@4, Exp 11/03/2013

Other Recalls from Leiter's Pharmacy

Recall # Classification Product Date
D-1041-2013 Class II Lidocaine/Phenylephrine PF 1%/1.5% Injectible v... Aug 26, 2013
D-1038-2013 Class II Dextrose 50% Preservative Free SDV Injection So... Aug 26, 2013
D-1039-2013 Class II Hyaluron (hyaluronidase) 150 units/mL Preserved... Aug 26, 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.