The Recall Desk
SevereFDA (Drugs)·D-0200-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Lidocaine HCl Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 7,275 syringes of Lidocaine HCl 2% because defective caps may compromise sterility. The product was distributed to hospitals nationwide.

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, meeting the criteria for a Severe rating.

Plain-English summary

SCA Pharmaceuticals is recalling 7,275 syringes of Lidocaine HCl 2% (20 mg/mL), 5 mL, Rx Only. The recall is due to a lack of assurance of sterility, caused by a potential for a defective syringe cap that may result in a non-integral unit.

The affected product was distributed to hospitals nationwide. The recall includes specific lots with expiration dates ranging from January 19, 2021, to February 10, 2021. The product is identified by barcode 70004072309.

Hospitals and healthcare facilities should stop using the affected syringes and contact SCA Pharmaceuticals for further instructions. Consumers should not use this prescription product unless directed by a healthcare professional.

The recalled product

Product
Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
Manufacturer
SCA Pharmaceuticals
Category
Drug — Injectable
Hazard
Affected units
7,275

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 (13)

  • Lot # 1220023034
  • BUD 1/19/2021
  • 1220023088
  • BUD 1/24/2021
  • 1220023112
  • BUD 1/25/2021
  • 1220023288
  • BUD 1/31/2021
  • 1220023323
  • BUD 2/2/2021
  • 1220023539
  • BUD 2/8/2021 & 1220023613
  • BUD 2/10/2021.

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 →

Related recalls

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Same hazard · sterility

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