SCA Pharmaceuticals: 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., Wind

Is my product affected?

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

• UPC 12200223400

Check against the official notice below — it lists the full affected range.

What happened

SCA Pharmaceuticals is recalling Buffered Lidocaine HCl, 1%, 5 mL syringes used for local anesthetic injection due to a lack of assurance of sterility and potential defective syringe caps that could result in non-integral units. The recall affects 3,793 syringes distributed to hospitals nationwide across six different lot numbers with beyond-use dates ranging from December 17, 2020 to December 27, 2020.

The source document does not specify what action affected consumers or facilities should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Details from the source

Reason for recall: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Distribution: Product was distributed to hospitals nationwide. Quantity: 3,793 syringes Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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