Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling 763 bags of compounded Oxytocin 30 units in Lactated Ringer's USP. The recall was initiated 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 injury or property damage reports, or in this case, a subpotent drug which poses a risk of treatment failure.
Plain-English summary
Pharmedium Services, LLC has voluntarily initiated a nationwide recall of 763 bags of Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bags. The product is prescription-only and was compounded by Pharmedium Services, LLC, located in Sugar Land, Texas. The recall covers all unexpired lots of the product, identified by NDC# 71019-243-04.
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 as labeled. 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.
Healthcare providers and patients who have used or possess this product should contact their healthcare provider or the recalling firm for further instructions. The recall was announced via press release.
The recalled product
- Product
- Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-04
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Drug
- Hazard
- Affected units
- 763
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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