SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL 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 where a lack of assurance of sterility poses a risk of harm (infection), but the source text does not report any illnesses or injuries, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
SCA Pharmaceuticals, LLC is conducting a voluntary recall of 451 bags of Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL). The recall is being issued due to a potential for leakage, which creates a lack of assurance of sterility for the sterile admixtures.
The affected product is identified by Lot # 20180323@24 with an expiration date of 06/21/2018. The product was distributed throughout the United States.
Consumers and healthcare providers should check their inventory for this specific lot number and discontinue use if found. No specific instructions for disposal or return are provided in the source text.
The recalled product
- Product
- Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Sterile Admixture
- Affected units
- 451
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 # 20180323@24
- Exp 06/21/2018
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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