Pharmedium Recalls Phenylephrine Injection Due to Human Hair Particulate Matter
Pharmedium Services is recalling 84 bags of Phenylephrine HCl injection because the sodium chloride base contained human hair.
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 per the rubric.
Plain-English summary
Pharmedium Services, LLC is recalling 84 bags of Phenylephrine HCl, 20 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 involves specific lots with expiration dates in February 2015.
The recall was initiated because the firm manufactured the products using Hospira 0.9% Sodium Chloride, USP injection, which was subsequently recalled due to the presence of particulate matter, specifically human hair. The affected product was distributed nationwide.
Healthcare providers and patients should stop using the affected lots and return them to the distributor or manufacturer for credit. Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice.
The recalled product
- Product
- PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injection
- Affected units
- 84
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 (6)
- Lot #: 14310063S
- Exp 02/04/15
- 14316086S
- Exp 02/10/15
- 14322138S
- Exp 02/16/15
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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