Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling 534 bags of compounded Oxytocin 30 units in 1000 mL bags because the drug was found to be subpotent.
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 adverse health consequences (subpotent drug) are assigned a score of 4 (Severe), as they are not Class I (Critical) but involve a significant risk of therapeutic failure.
Plain-English summary
Pharmedium Services, LLC has initiated a voluntary recall of 534 bags of Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP. The product is compounded by Pharmedium Services, LLC, located in Sugar Land, Texas, and is identified by NDC# 71019-242-02. The recall covers all unexpired lots.
The reason for the recall is that the drug was found to be subpotent, meaning it may not contain the full labeled amount of the active ingredient. The FDA has classified this recall as Class II, indicating a situation where use of the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected product was distributed nationwide. Healthcare providers and patients who have used or possess this specific compounded medication should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or seek alternative treatment. The recall was initiated on September 1, 2017, and was terminated on January 24, 2020.
The recalled product
- Product
- Oxytocin 30 units added to 1000 mL 5% Dextrose/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# 71019-242-02
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 534
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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