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.
What this means for you
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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