Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling 90 bags of compounded Oxytocin 40 units in Lactated Ringer's because the drug was subpotent.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are mapped to a score of 4 (Severe), particularly when the defect involves a significant deviation like subpotency in a critical medication.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 90 bags of Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bags. The product is prescription-only and was compounded by Pharmedium Services, LLC, located in Sugar Land, Texas. The recall covers all unexpired lots of this specific product.
The recall was initiated because the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled. The recall is voluntary and was initiated by the firm. The affected product was distributed nationwide.
The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The recall status is currently terminated.
The recalled product
- Product
- Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-245-03
- Manufacturer
- Pharmedium Services, LLC
- Hazard
- Affected units
- 90
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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