LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml...
FDA Drug Recall #D-1789-2019 — Class II — June 12, 2019
Recall Summary
| Recall Number | D-1789-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 12, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Infusion Options, Inc. |
| Location | Brooklyn, NY |
| Product Type | Drugs |
| Quantity | N/A |
Product Description
LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCOVORIN 750 MG / 250 ml NS IVPB; LEUCOVORIN 690 MG / 250 ml NS IVPB; LEUCOVORIN 314 mg / 50 ml NS IVPB; LEUCOVORIN 620 MG / 250 ml D5W IVPB; LEUCOVORIN 420 MG / 50 ML D5W IVPB; LEUCOVORIN 700 MG / 250 ml D5W IVPB; LEUCOVORIN 592 mg / 250 ml D5W IVPB; LEUCOVORIN 760 mg / 250 ml D5W IVPB; LEUCOVORIN 796 MG / 250 ml D5W IVPB; LEUCOVORIN 730 MG / 250 ml D5W IVPB; LEUCOVORIN 324 mg / 50 ml NS IVPB; LEUCOVORIN 590 MG / 250 ml D5W IVPB; LEUCOVORIN 336 MG / 50 ml NS IVPB; LEUCOVORIN 398 MG/ 250 ml D5W IVPB; LEUCOVORIN 354 MG / 50 ml NS IVPB; LEUCOVORIN 720 MG / 250 ml D5W IVPB; LEUC; VORIN 328 mg / 50 ml NS IVPB; LEUCOVORIN 776 MG / 250 ml D5W IVPB; LEUCOVORIN 339 MG / 250 ml D5W IVPB; LEUCOVORIN 800 mg / 250 ml D5W IVPB; LEUCOVORIN 330 MG / 50 ml D5W IVPB; LEUCOVORIN 330 MG / 50 ml NS IVPB; LEUCOVORIN 688 MG in 250 ML D5W IVPB; LEUCOVORIN 350 MG / 250 ml NS IVPB; LEUCOVORIN 672 MG / 250 ml D5W IVPB; LEUCOVORIN 588 mg / 250 ml D5W IVPB; LEUCOVORIN 812 MG / 250 ML D5W IVPB; LEUCOVORIN 300 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
NY only
Lot / Code Information
All lots within expiry
Other Recalls from Infusion Options, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1786-2019 | Class II | INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER... | Jun 12, 2019 |
| D-1746-2019 | Class II | Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusio... | Jun 12, 2019 |
| D-1768-2019 | Class II | DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusi... | Jun 12, 2019 |
| D-1769-2019 | Class II | DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71... | Jun 12, 2019 |
| D-1814-2019 | Class II | TOPOTECAN 1.24 MG / 100 ML NS IVPB, Rx Only, In... | Jun 12, 2019 |
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.