SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL). The recall is being issued 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 # 20180323@29 with an expiration date of 06/21/2018. The product was distributed throughout the United States.
Consumers and healthcare providers should discontinue use of the affected lots and contact SCA Pharmaceuticals, LLC for further instructions or a replacement.
The recalled product
- Product
- Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Sterile Admixture
- Affected units
- 400
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@29
- 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.
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