Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide
Pharmedium Services, LLC is recalling 1,308 bags of compounded Oxytocin 10 units in Lactated Ringer's Injection because the drug was 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm (subpotent drug) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High (3) due to the agency's specific classification of the defect.
Plain-English summary
Pharmedium Services, LLC has voluntarily recalled 1,308 bags of Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP. The product is a prescription-only compounded medication identified by NDC# 71019-237-01. The recall covers all unexpired lots of this specific product.
The FDA classified this recall as Class II because the product was found to be subpotent, meaning it contained less than the labeled amount of the active ingredient. The recall was initiated by the firm and distributed nationwide. The recall was initiated on September 1, 2017, and was terminated on January 24, 2020.
Patients who have received this medication should contact their healthcare provider or pharmacist for guidance. The recall was announced via press release.
The recalled product
- Product
- Oxytocin 10 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# 71019-237-01
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 1,308
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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