US Compounding Recalls Mislabeled Ephedrine Sulfate Injection Syringes
US Compounding Inc is recalling 762 syringes of ephedrine sulfate injection due to a labeling error on the outer protective bags that could cause confusion regarding the drug's strength.
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 minor labeling error on the outer packaging where the actual syringes were correctly labeled, fitting the criteria for moderate severity.
Plain-English summary
US Compounding Inc is recalling 762 syringes of ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL). The recall is due to a labeling error on the outer light protective bags where the syringes are stored. The outer bags were mislabeled with "25 mg/mL" in large font and "5 mg/mL" in small font, although the actual syringes were correctly labeled as 25 mg/5 mL.
The product is a single-use 5 mL syringe intended for IV, IM, or SC injection. It is preservative-free and designated for office or hospital use only. The affected lot number is 20142104@30, with a use-by date of 10/18/2014.
The product was distributed nationwide. Healthcare providers and patients should stop using the affected product and contact US Compounding Inc at 800-718-3588 for further instructions.
The recalled product
- Product
- ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injection
- Hazard
- Affected units
- 762
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# 20142104@30 USE BY: 10/18/2014
Distribution
Distributed nationwide across the United States.
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