Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide
Pharmedium Services is voluntarily recalling 42 bags of compounded Oxytocin 40 units in Lactated Ringer's solution 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 with potential for significant injury or hospitalization (implied by subpotent critical care medication) are rated Severe (4).
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 42 bags of Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bags. The recall was initiated on September 1, 2017, and the product was distributed nationwide. The FDA classified this recall as Class II.
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 required. The recall covers all unexpired lots of the product, identified by NDC# 71019-245-04. The recall status is currently terminated as of January 24, 2020.
Healthcare providers and patients who have this specific compounded medication should contact their pharmacist or healthcare provider for guidance on whether to discontinue use or obtain a replacement. The recall was initiated by the firm and notified via press release.
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# 71019-245-04
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 42
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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