SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL bags due to a potential for leakage that compromises sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical product with a potential for leakage compromising sterility, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
SCA Pharmaceuticals, LLC is conducting a voluntary recall of certain lots of Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL bags (200 mcg/mL). The recall is being initiated due to a lack of assurance of sterility resulting from a potential for leakage in the sterile admixtures.
The affected product is identified by Lot # 20180329@2 with an expiration date of 06/27/2018. The product was distributed throughout the United States.
Healthcare providers and patients should discontinue use of the affected lots and contact SCA Pharmaceuticals for further instructions or replacement.
The recalled product
- Product
- Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Sterile Admixture
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 # 20180329@2
- Exp 06/27/2018
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by SCA Pharmaceuticals, 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.
See all 12 products in this recall →Related recalls
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