Pharmedium Recalls Subpotent Oxytocin Lactated Ringer's Injection Bags
Pharmedium Services, LLC is voluntarily recalling 978 bags of compounded Oxytocin in Lactated Ringer's Injection 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II for a subpotent drug, which fits the rubric for 'risk-of-harm products where injury has not yet been reported' or significant potential for adverse health consequences without confirmed fatalities.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 978 bags of Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP. The product is compounded in 1000 mL bags and is available by prescription only. The recall covers all unexpired lots of the product.
The recall was initiated because the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled. The FDA classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The product was distributed nationwide. The recall was initiated on September 1, 2017, and was terminated on January 24, 2020. Consumers and healthcare providers should check their inventory for this specific product and NDC number (71019-241-05) and contact the recalling firm or their pharmacy for further instructions.
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# 71019-241-05.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 978
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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