PharMEDium Recalls Epinephrine Injection Bags Due to Particulate Matter
PharMEDium Services is recalling 36 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 FDA has classified this recall as Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
PharMEDium Services, LLC is recalling 36 bags of EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL). The product is packaged in 250 mL bags and is prescription only. The specific lot number is 15033045S, 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 FDA has classified this recall as Class I.
The affected product was distributed nationwide. Consumers and healthcare providers should discontinue use of the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6244, NDC# 61553-244-61.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 36
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 #: 15033045S
- 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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