PharMEDium 0.2% Ropivacaine Epidural Cassettes Recall: Sterility Risk
PharMEDium recalls 250mL epidural anesthetic cassettes due to potential sterility issues. Product may be contaminated with endotoxins from improper testing.
Lower-risk recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Contact the company
What happened, in plain English
PharMEDium is recalling 250mL epidural anesthetic cassettes that may be contaminated with endotoxins. This could lead to infections or other complications during medical procedures. Read more at govinfonow.com/recall/40889-pharmedium-0-2-ropivacaine-epidural-cassettes-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40889-pharmedium-0-2-ropivacaine-epidural-cassettes-recall-sterility-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0423-2018
Cite this page
“PharMEDium 0.2% Ropivacaine Epidural Cassettes Recall: Sterility Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40889-pharmedium-0-2-ropivacaine-epidural-cassettes-recall-sterility-risk. Based on FDA recall #D-0423-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0423-2018%22&limit=1).
Why it’s dangerous
The product may have been contaminated with endotoxins due to improper testing procedures. Endotoxins are bacterial components that can cause serious infections or adverse reactions when injected into the body.
Who’s affected
Healthcare providers using these cassettes for epidural anesthesia. Patients receiving the medication during procedures are at risk if the product is contaminated.
How to tell if you have this one
Check for the yellow cassette labeled '0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL'. Lot numbers 180030029D with expiration date 2/18/18 are affected.
- Brand
PharMEDium- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was distributed to SC, FL, NY, NY,WA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0422-2018 | 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC; Lot #: 180040003D, Exp 3/18/18 | 24 Viaflex Bag |
| D-0423-2018 | 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC; Lot #: 180030029D, Exp 2/18/18 | 21 Cassettes |
| D-0424-2018 | 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC; Lot #: 180080063D, Exp 4/9/18 | 500 syringes |
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the cassette to determine if it's affected.
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “Product was distributed to SC, FL, NY, NY,WA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, New York, South Carolina, Washington.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The product may be contaminated with endotoxins, so it should not be used until the recall is resolved.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0423-2018 (February 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0423-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.