US Compounding Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
US Compounding Inc is recalling 1,686 syringes of Ephedrine Sulfate 50 mg/10 mL because the company cannot ensure the product is sterile.
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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury risks such as sterility failures in injectable medications.
Plain-English summary
US Compounding Inc is recalling 1,686 single-use syringes of Ephedrine Sulfate, 50 mg/10 mL. The product is prescription-only and was distributed nationwide in the United States. The specific lot number is 20181812@2, with a beyond-use date of 06/16/2019.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the medication is free from microorganisms, which poses a risk of infection if administered.
Consumers and healthcare providers should stop using the affected product immediately. Those who have received this medication should contact their healthcare provider for guidance on next steps and potential alternative treatments.
The recalled product
- Product
- Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable Medication
- Affected units
- 1,686
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: 20181812@2 BUD: 06/16/2019
Distribution
Distributed nationwide across the United States.
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