Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling 390 bags of compounded Oxytocin 20 units in Lactated Ringer's Injection due to subpotent drug levels.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II for a subpotent drug, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pharmedium Services, LLC has voluntarily initiated a recall of 390 bags of Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP. The product is compounded by PharMEDium Services, LLC, located in Sugar Land, Texas, and is identified by NDC# 71019-241-04. The recall covers all unexpired lots of this specific compounded medication.
The reason for the recall is that the drug was found to be subpotent, meaning it contained less of the active ingredient than required. This classification is designated as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The product was distributed nationwide. Healthcare providers and patients who have used or possess this specific compounded oxytocin product should contact their pharmacist or healthcare provider for guidance on replacement or further medical evaluation.
The recalled product
- Product
- Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-04
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 390
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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