SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL due to potential 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant risks or specific agency classifications are mapped to a score of 4 (Severe) to ensure appropriate visibility, as Class I is reserved for the highest risk (5) and Class III for lower risk (1-2).
Plain-English summary
SCA Pharmaceuticals, LLC is conducting a voluntary recall of 451 bags of Phenylephrine HCL 40 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@24. The product was distributed throughout the United States. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact SCA Pharmaceuticals, LLC for further instructions or a refund.
The recalled product
- Product
- Phenylephrine HCL 40 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
- 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 (1)
- Lot # 20180323@24
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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