SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Labeling Error
SCA Pharmaceuticals is recalling 50 bags of phenylephrine HCl 50 mg in 0.9% sodium chloride due to a label mix-up. The product was incorrectly labeled instead of phenylephrine in 5% dextrose.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (label mix-up) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
SCA Pharmaceuticals is recalling 50 bags of PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bags. The recall was initiated because of a labeling error where the product was incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
The affected product is prescription-only and is identified by Lot 20150423@47 with an expiration date of 07/22/15. The distribution pattern is listed as CA.
Consumers and healthcare providers should stop using the affected product and contact SCA Pharmaceuticals at (877) 550-5059 for further instructions.
The recalled product
- Product
- PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029.
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 50
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: 20150423@47
- Exp 07/22/15
Distribution
Distributed in 1 state:
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