Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide
Pharmedium Services, LLC is voluntarily recalling 1,152 bags of compounded Oxytocin 40 units in Lactated Ringer's USP 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, and the hazard involves a subpotent drug, which poses a risk of treatment failure but is not associated with reported deaths or serious injuries in the source text.
Plain-English summary
Pharmedium Services, LLC has voluntarily recalled 1,152 bags of Oxytocin 40 units added to 1000 mL Lactated Ringer's USP. The product is a prescription-only compounded medication identified by NDC# 71019-245-02. The recall covers all unexpired lots of this specific product.
The reason for the recall is that the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled. The recall was initiated by the firm on September 1, 2017, and was classified as Class II by the FDA. The product was distributed nationwide.
Healthcare providers and patients who have this product should stop using it and contact Pharmedium Services, LLC for further instructions. The recall status is currently terminated, having been closed on January 24, 2020.
The recalled product
- Product
- Oxytocin 40 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# 71019-245-02
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Prescription
- Hazard
- Affected units
- 1,152
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.
See all 15 products in this recall →Related recalls
Same manufacturer · Pharmedium Services, LLC
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
Same hazard · subpotent drug
See all →- LowImprimisRx Recalls Subpotent Povidone Iodine and Proparacaine Ophthalmic Solution
FDA (Drugs) · 2026-09-16
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
Similar recalls
- SeverePharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Oxytocin Lactated Ringers Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- HighInjectable oxyTOCIN and Lactated Ringer's Recalled Over Sterility Concerns
FDA (Drugs) · 2023-05-31
- SeverePharmedium Recalls Oxytocin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2015-09-02
- HighOxytocin and Lactated Ringer's Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2023-05-31
- HighFDA Recalls Oxytocin Injectable Bags Due to Sterility Assurance Failure
FDA (Drugs) · 2023-05-31