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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

PharMEDium Services, LLC: Oxytocin, Ropivacaine, and Phenylephrine Recalled for Sterility Concerns

Agency Publication Date: March 29, 2018
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Summary

PharMEDium Services, LLC has recalled 545 units of injectable medications, including Oxytocin, Ropivacaine HCI, and Phenylephrine HCl, due to a lack of assurance of sterility. Three specific lots were released after the company failed to follow proper testing and investigation procedures, meaning the products may contain higher-than-allowed levels of endotoxins. These prescription medications are administered in healthcare settings via IV bags, cassettes, or syringes and were distributed to facilities in South Carolina, Florida, New York, and Washington. Consumers should contact their healthcare provider or pharmacist immediately if they have received these medications and believe they are experiencing any related issues.

Risk

Products with compromised sterility or excessive endotoxin levels can cause serious infections or inflammatory responses when injected. Because these drugs are administered directly into the bloodstream or epidural space, any contamination poses a medium risk of patient illness or adverse medical reactions.

What You Should Do

  1. Check your medical records or contact your healthcare provider to see if you received Oxytocin (15 units in 0.9% Sodium Chloride, 250 mL Viaflex Bag) from lot 180040003D with an expiration date of 3/18/18.
  2. Identify if you were treated with 0.2% Ropivacaine HCI (Preservative Free) in 0.9% Sodium Chloride (250 mL Yellow Cassette) from lot 180030029D with an expiration date of 2/18/18.
  3. Determine if you received 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection (10 mL syringe) from lot 180080063D with an expiration date of 4/9/18.
  4. If you have any of these unused products in your possession, stop using them immediately and return them to the pharmacy or place of purchase for a refund.
  5. Contact your healthcare provider or pharmacist for guidance if you have concerns about medications you have already received.
  6. Contact PharMEDium Services, LLC at their Dayton, New Jersey facility for further instructions regarding this recall.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Oxytocin added to 0.9% Sodium Chloride Injection (250 mL Viaflex Bag)
Model:
D-0422-2018
Lot Numbers:
180040003D (Exp 3/18/18)
Date Ranges: 3/18/18
Product: 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride (250 mL Yellow Cassette)
Model:
D-0423-2018
Lot Numbers:
180030029D (Exp 2/18/18)
Date Ranges: 2/18/18
Product: 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection (10 mL syringe)
Model:
D-0424-2018
Lot Numbers:
180080063D (Exp 4/9/18)
Date Ranges: 4/9/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79063
Status: Resolved
Manufacturer: PharMEDium Services, LLC
Sold By: Hospitals; Healthcare Facilities
Manufactured In: United States
Units Affected: 3 products (24 Viaflex Bag; 21 Cassettes; 500 syringes)
Distributed To: South Carolina, Florida, New York, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.