Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling 564 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 recall is classified as FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a product that could cause temporary or medically reversible adverse health consequences.
Plain-English summary
Pharmedium Services, LLC has voluntarily initiated a recall of 564 bags of Oxytocin 10 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 available by prescription only. 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 recall was initiated on September 1, 2017, and was classified as Class II by the FDA. The recall status is currently terminated as of January 24, 2020.
The affected product was distributed nationwide. Healthcare providers and patients who have this specific compounded medication should contact their pharmacist or healthcare provider for guidance on replacement or disposal. The recall was announced via a press release.
The recalled product
- Product
- Oxytocin 10 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# 71019-237-03
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 564
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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