Agency classClass IIOur severity:Severe FDA (Drugs)·D-0199-2021·Announced 2021-01-13

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: sterility
defective-packaging
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.

See all 32 products in this recall →

Same manufacturer · SCA Pharmaceuticals

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Same hazard · sterility