Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling 24,486 bags of compounded Oxytocin 30 units in Lactated Ringer's because the drug was 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 injury/property-damage reports or structural defects, though the rubric explicitly maps Class II to Severe in the absence of Class I criteria.
Plain-English summary
Pharmedium Services, LLC has voluntarily initiated a recall of 24,486 bags of Oxytocin 30 units added to 500 mL Lactated Ringer's USP. The product is a prescription-only compounded medication distributed nationwide. The recall was initiated because the drug was found to be subpotent, meaning it did not contain the full amount of the active ingredient.
The recall covers all unexpired lots of the product. The recall was initiated on September 1, 2017, and was terminated on January 24, 2020. The FDA classified this recall as Class II, which indicates 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.
Healthcare providers and patients should stop using the affected product and contact Pharmedium Services, LLC or their pharmacy for further instructions. The recall was initiated by the firm and notified via press release.
The recalled product
- Product
- Oxytocin 30 units added to 500 mL 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# 71019-243-03
- Manufacturer
- Pharmedium Services, LLC
- Hazard
- Affected units
- 24,486
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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