Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling 60 bags of compounded Oxytocin injection because the drug was found to be 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant potential health impacts like subpotency in a critical medication.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 60 bags of Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP. The product is compounded by Pharmedium Services, LLC, located in Sugar Land, Texas, and is identified by NDC# 71019-241-03. The recall covers all unexpired lots of this specific compounded product.
The reason for the recall is that the drug was found to be subpotent, meaning it may not contain the full intended amount of the active ingredient. 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 product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific product and stop using it if found. The recall was initiated by the firm and was later terminated by the FDA.
The recalled product
- Product
- Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-03
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 60
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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