Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling Oxytocin 20 units in Lactated Ringer's Injection USP bags 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by subpotent drug status in a critical care setting) map to a score of 4 (Severe), as Class I is required for a score of 5.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bags. The recall was initiated because the product was found to be subpotent, meaning it contained less than the labeled amount of the active ingredient. The recall covers all unexpired lots of the product, which is identified by NDC# 71019-241-06.
The affected product was distributed nationwide. The recall was initiated on September 1, 2017, and was classified as Class II by the FDA. The recall status is currently terminated, with a termination date of January 24, 2020.
Healthcare providers and patients should stop using the affected product and contact Pharmedium Services, LLC for further instructions or replacement. The firm notified the public via a press release.
The recalled product
- Product
- Oxytocin 20 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# 71019-241-06
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
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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