PharMEDium Services, LLC recalls 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
PharMEDium Services recalls 10 mg/mL Roc: 5mL BD syringes due to CGMP deviations during hood certification investigation. Affected lots: 181780003D. No remedy specified in recall notice.
Recall notice
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Contact the company & request your remedy
What happened, in plain English
PharMEDium Services is recalling 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD syringes because of CGMP deviations during a hood certification investigation. This recall does not involve a specific safety risk to users but is a regulatory action to address manufacturing compliance issues. Read more at govinfonow.com/recall/39866-pharmedium-10-mg-ml-rocuronium-bromide-5ml-syringe-recall-cgmp.
Source Summary by GovInfoNow · govinfonow.com/recall/39866-pharmedium-10-mg-ml-rocuronium-bromide-5ml-syringe-recall-cgmp · Updated October 6, 2026 · FDA enforcement record: FDA #D-1045-2018
Cite this page
“PharMEDium 10 mg/mL Rocuronium Bromide 5mL Syringe Recall: CGMP Deviations.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39866-pharmedium-10-mg-ml-rocuronium-bromide-5ml-syringe-recall-cgmp. Based on FDA recall #D-1045-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1045-2018%22&limit=1).
Why it’s dangerous
The product was released while a hood certification discrepancy was being investigated, indicating potential regulatory non-compliance. This could affect product quality and safety standards, though the recall does not specify immediate user risks.
Who’s affected
Healthcare professionals using the recalled syringes for anesthesia administration are likely affected. The recall targets specific lots produced by PharMEDium Services.
How to tell if you have this one
Check for the lot number 181780003D on the syringe packaging. The product is a 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD syringe manufactured by PharMEDium Services.
- 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 throughout the United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1043-2018 | 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.; Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018 | 230 Intravia Bags |
| D-1044-2018 | 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.; Lot 181730039D, Exp 09/20/2018 | 450 Syringes |
| D-1045-2018 | 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.; Lot 181780003D | 575 Syringes |
What to do — step by step
Check Product Lot Number
Look for the lot number 181780003D on the syringe packaging to confirm if it is affected.
Questions people ask
Is there a risk of serious injury from this product?
The recall notice does not specify any safety risk to users; it addresses CGMP deviations during manufacturing.
What should I do if I have the recalled product?
The recall notice does not provide a remedy; check the lot number to confirm if it is affected.
How can I verify if my syringe is part of this recall?
Check for the lot number 181780003D on the syringe packaging. The product is a 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD syringe from PharMEDium Services.
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-1045-2018 — PharMEDium PharMEDium Hello, I own a PharMEDium that is covered by recall D-1045-2018 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-1045-2018 (July 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1045-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.