Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling 4,452 bags of compounded Oxytocin 30 units due to subpotent drug levels. The FDA classified this as a Class II recall.
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. According to the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe (Score 4), as they are not Class I (Critical) but represent a significant risk requiring recall.
Plain-English summary
Pharmedium Services, LLC has voluntarily initiated a nationwide recall of 4,452 bags of Oxytocin 30 units added to 500 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# 71019-242-01. The recall covers all unexpired lots of the product.
The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full amount of the active ingredient required. 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 was initiated on September 1, 2017, and was reported to the FDA on November 1, 2017. The firm notified the public via a press release. The recall status is currently terminated, with a termination date of January 24, 2020. Consumers and healthcare providers should check their inventory for this specific product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Oxytocin 30 units added to 500 mL 5% Dextrose/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# 71019-242-01
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Infusion
- Hazard
- Affected units
- 4,452
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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