Pharmedium Recalls Phenylephrine Injection Bags Due to Particulate Matter
Pharmedium Services is recalling 120 bags of Phenylephrine HCl injection due to the presence of human hair 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 severity score of at least 4 per the rubric.
Plain-English summary
Pharmedium Services, LLC is recalling 120 bags of Phenylephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP. The product is packaged in 250 ml bags and is available by prescription only. The recall covers two specific lots: 14308086S (expiring 02/02/15) and 14309051S (expiring 02/03/15).
The recall was initiated because the products were manufactured using Hospira 0.9% Sodium Chloride, USP injection, which was previously recalled due to the presence of particulate matter, specifically human hair. The distribution of the affected product was nationwide.
Healthcare providers and patients should check their inventory for the specific NDC number 61553-149-50 and the lot numbers listed above. If the product is found, it should be quarantined and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 120
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 (4)
- Lot #: 14308086S
- Exp 02/02/15
- 14309051S
- Exp 02/03/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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