SCA Pharmaceuticals Recalls Esmolol Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 952 syringes of Esmolol HCl 100 mg/10 mL due to a lack of assurance of sterility and potential defective caps.
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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
SCA Pharmaceuticals is recalling 952 syringes of Esmolol HCl 100 mg/10 mL (10 mg/mL), 10 mL Single Dose Syringe, Rx Only. The affected product is identified by Lot # 1220023042 and has a beyond-use date of 1/21/2021. The product was distributed to hospitals nationwide.
The recall was initiated due to a lack of assurance of sterility. There is a potential for a defective syringe cap, which could result in a non-integral unit. This defect may compromise the sterility of the medication.
Hospitals and healthcare facilities that received this product should stop using the affected syringes and contact SCA Pharmaceuticals for further instructions. Patients who have already received the medication should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 952
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 # 1220023042
- BUD 1/21/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by SCA Pharmaceuticals 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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