Agency classClass IIOur severity:Severe FDA (Drugs)·D-0187-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Buffered Lidocaine Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 3,793 syringes of Buffered Lidocaine HCl due to a potential defective cap that compromises sterility. The product was distributed to hospitals nationwide.

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. According to the rubric, an FDA Class II recall involving a risk of serious health consequences (loss of sterility in an injectable drug) is categorized as Severe.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 3,793 syringes of Buffered Lidocaine HCl, 1%, 5 mL with Sodium Bicarbonate Injection. The recall is being conducted because of a lack of assurance of sterility, which may be caused by a defective syringe cap resulting in a non-integral unit.

The affected product is a prescription-only local anesthetic used in single-dose syringes. The specific lots involved are 1220023305, 12200223400, 1220023536, 1220023608, 1220023811, and 1220023812, with expiration dates ranging from December 17, 2020, to December 27, 2020.

The product was distributed to hospitals nationwide. Healthcare facilities should stop using the affected syringes and contact SCA Pharmaceuticals for further instructions regarding the return or disposal of the product.

The recalled product

Product: Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Anesthetic
Hazard: sterility
infection-risk
Affected units: 3,793

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 (11)

Lot # 1220023305
BUD 12/17/2020
12200223400
BUD 12/19/2020
1220023536
BUD 12/25/2020
1220023608
BUD 12/27/2020
1220023811
BUD 12/26/2020 & 1220023812
BUD 12/26/2020.

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