Pharmedium Services, LLC recalls Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL
PharMEDium Services recalls specific fentanyl and ropivacaine injections due to sub-potent risk. Learn product details and safety steps.
Lower-risk recall
Sub-potent
Contact the company & request your remedy
What happened, in plain English
PharMEDium Services recalled certain fentanyl and ropivacaine injections because they may be less potent than intended. This could lead to ineffective pain management during medical procedures. Read more at govinfonow.com/recall/39383-pharmedium-fentanyl-ropivacaine-injections-recall-sub-potent-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39383-pharmedium-fentanyl-ropivacaine-injections-recall-sub-potent-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0334-2019
Cite this page
“PharMEDium Fentanyl Ropivacaine Injections Recall: Sub-potent Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39383-pharmedium-fentanyl-ropivacaine-injections-recall-sub-potent-risk. Based on FDA recall #D-0334-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0334-2019%22&limit=1).
Why it’s dangerous
Sub-potent means the medication may not work as intended at the prescribed dose. This could result in inadequate pain relief during medical procedures.
Who’s affected
Healthcare providers who use these injections for medical procedures may be affected. Patients receiving these injections under medical supervision are at low risk.
How to tell if you have this one
Check for the NDC code 61553-148-48 and expiration date 02/17/2019 on the 150 mL Intravia Bag packaging.
- Brand
PharMEDium- Category
Drug
All 2 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
Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0333-2019 | Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.; Lot: 183220013C Exp. 12/19/2018 | 295 50 ml in 60 ml syringes |
| D-0334-2019 | Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48; Lot: 183230004C Exp. 02/17/2019 | 295 100 mL in 150 mL Intravia bags |
What to do — step by step
Check Product Details
Look for the NDC code 61553-148-48 and expiration date 02/17/2019 on the 150 mL Intravia Bag packaging.
Questions people ask
Is this product safe to use?
The recall is due to sub-potent risk, meaning it may not work as intended. Healthcare providers should not use these specific injections.
How can I tell if I have the recalled product?
Check for the NDC code 61553-148-48 and expiration date 02/17/2019 on the 150 mL Intravia Bag packaging.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact PharMEDium Services for guidance.
Contact PharMEDium
We’ve drafted a message you can send PharMEDium to request your refund or repair — edit it as you like.
Subject: Recall D-0334-2019 — PharMEDium PharMEDium Hello, I own a PharMEDium that is covered by recall D-0334-2019 from PharMEDium. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0334-2019 (December 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0334-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.