Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: ...
FDA Drug Recall #D-0615-2017 — Class II — March 10, 2017
Recall Summary
| Recall Number | D-0615-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 10, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Claris Lifesciences Inc |
| Location | North Brunswick, NJ |
| Product Type | Drugs |
| Quantity | 24,456 units (1019 cartons x 24 bags) |
Product Description
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
Reason for Recall
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Distribution Pattern
Nationwide
Lot / Code Information
Lot #: A060040, Exp. Dec 2017
Other Recalls from Claris Lifesciences Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0127-2018 | Class III | Ciprofloxacin in Dextrose (5%) Injection, USP 2... | Nov 6, 2017 |
| D-0614-2017 | Class II | Fluconazole Injection, USP, 400 mg in 200 mL, R... | Mar 10, 2017 |
| D-0613-2017 | Class II | Ciprofloxacin in Dextrose (5%) Injection, USP, ... | Mar 10, 2017 |
| D-0616-2017 | Class II | Metronidazole Injection, USP, 500 mg/100 mL, Rx... | Mar 10, 2017 |
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.