SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling 196 bags of Phenylephrine HCL 80mg in 0.9% Sodium Chloride 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 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 II, and the hazard involves a lack of assurance of sterility in a sterile admixture, which poses a significant risk of infection or serious injury.
Plain-English summary
SCA Pharmaceuticals, LLC is conducting a voluntary recall of 196 bags of Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL). The product is manufactured in Windsor, CT, and was distributed throughout the United States.
The recall is being conducted due to a lack of assurance of sterility resulting from a potential for leakage in the sterile admixtures. The specific lot affected is # 20180328@25, with an expiration date of 06/26/2018.
Healthcare providers and patients should check their inventory for this specific lot number and expiration date. If the product is found, it should be removed from use and returned to the supplier or the recalling firm.
The recalled product
- Product
- Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Sterile Admixture
- Affected units
- 196
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 # 20180328@25
- Exp 06/26/2018
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.
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