PharMEDium Recalls Epinephrine Injection Bags Due to Particulate Matter
PharMEDium Services, LLC is recalling 48 bags of Epinephrine HCl injection due to the presence of particulate matter in the solution.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
PharMEDium Services, LLC is recalling 48 bags of EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP. The product is packaged in 250 mL bags and is prescription only. The specific lot number is 15033060S with an expiration date of 05/03/15.
The recall was initiated because the firm produced products 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 agency has classified this recall as Class I.
Healthcare providers and patients should stop using the affected product immediately. The recall is distributed nationwide.
The recalled product
- Product
- EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6618, NDC# 61553-618-61.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 48
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 #: 15033060S
- Exp 05/03/15
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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