Pharmedium Recalls Oxytocin Injection Bags Due to Particulate Matter
Pharmedium Services, LLC is recalling 72 bags of oxyTOCIN 15 Units in 5% Dextrose Injection due to the presence of particulate matter.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 72 bags of oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP. The product is packaged in 250 mL bags and is available by prescription only. The specific lot number is 15041113S, with an expiration date of 04/23/15.
The recall was initiated because the products were produced using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, which were subsequently recalled by the manufacturer due to the presence of particulate matter. The distribution of the affected product was nationwide.
Healthcare providers and consumers should stop using the affected product immediately. Patients who have received this product should contact their healthcare provider for further instructions.
The recalled product
- Product
- oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 72
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 (2)
- Lot #: 15041113S
- Exp 04/23/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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