Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide
Pharmedium Services is recalling 6,108 bags of compounded Oxytocin 30 units in Lactated Ringer's because the drug was subpotent. The recall is voluntary and nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant health impact (subpotent drug) are rated as Severe (4), as they are not Class I but involve a significant defect.
Plain-English summary
Pharmedium Services, LLC has voluntarily recalled 6,108 bags of Oxytocin 30 units added to 500 mL Lactated Ringer's USP. The product is compounded in 500 mL bags and is prescription-only. The recall covers all unexpired lots distributed nationwide.
The recall was initiated because the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled. The FDA classified this recall as Class II, indicating a situation that could cause temporary or medically reversible health problems.
Healthcare providers and patients who have received this product should contact their pharmacist or the recalling firm for instructions on how to return the product. The recall was initiated on September 1, 2017, and was terminated on January 24, 2020.
The recalled product
- Product
- Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-243-01
- Manufacturer
- Pharmedium Services, LLC
- Hazard
- Affected units
- 6,108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All unexpired lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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