METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home In...
FDA Drug Recall #D-0304-2023 — Class II — December 27, 2022
Recall Summary
| Recall Number | D-0304-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 27, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Sentara Infusion Services |
| Location | Chesapeake, VA |
| Product Type | Drugs |
| Quantity | 19 syringes |
Product Description
METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason for Recall
Lack of sterility assurance
Distribution Pattern
Dispensed to Patients Nationwide.
Lot / Code Information
Beyond Use Date: December 28-29, 2022
Other Recalls from Sentara Infusion Services
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0296-2023 | Class II | HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 1... | Dec 27, 2022 |
| D-0323-2023 | Class II | VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS... | Dec 27, 2022 |
| D-0306-2023 | Class II | METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only,... | Dec 27, 2022 |
| D-0297-2023 | Class II | IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibio... | Dec 27, 2022 |
| D-0321-2023 | Class II | TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)T... | Dec 27, 2022 |
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.