SCA Pharmaceuticals Recalls Lidocaine HCl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling Lidocaine HCl 1% syringes 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 a medical product, which poses a significant risk of infection or injury.
Plain-English summary
SCA Pharmaceuticals is recalling Lidocaine HCl 1% 10 mL (10mg/ml) single-dose syringes. The recall is due to a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit.
The affected product was distributed to hospitals nationwide. The recall involves 1,880 syringes from specific lots with expiration dates in January and February 2021.
Hospitals and healthcare facilities should check their inventory for the affected lot numbers and stop using the product. Consumers should not use this prescription medication if they have it in their possession.
The recalled product
- Product
- Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Affected units
- 1,880
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 (5)
- Lot # 1220023097
- BUD 1/25/2021
- 1220023134
- BUD 1/25/2021 & 1220023326
- BUD 2/1/2021
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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