Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals: Buffered Lidocaine Injection Recalled for Subpotency and Stability Issues

Agency Publication Date: July 10, 2018

Summary

SCA Pharmaceuticals is recalling 3,984 syringes of Buffered Lidocaine 1% with Sodium Bicarbonate Injection (10 mg/mL), a prescription local anesthetic. The recall was issued because stability testing showed the drug may become subpotent before its labeled 55-day expiration date. This means the medication may not be strong enough to provide effective numbing during medical procedures. Consumers should contact their healthcare provider or pharmacist regarding any unused syringes from the affected lots.

Risk

Because the drug is subpotent, it may fail to provide the intended level of local anesthesia, potentially causing patients to experience unexpected pain or discomfort during surgical or medical procedures.

What You Should Do

Identify if you have the affected Buffered Lidocaine 1% with Sodium Bicarbonate Injection (10 mg/mL) 0.25 mL syringes by checking the lot numbers and expiration dates on the packaging.
Locate the following specific lot numbers and expiration dates: Lot 20180507@21 (Exp 7/1/2018); Lots 20180511@9 and 20180511@24 (Exp 7/5/2018); Lots 20180518@24, 20180518@31, and 20180518@32 (Exp 7/12/2018); Lot 20180531@21 (Exp 7/25/2018); and Lot 20180601@11 (Exp 7/26/2018).
Immediately stop using any product from these identified lots and contact your pharmacist or healthcare provider for guidance on returning the medication.
Return any unused syringes to the place of purchase or pharmacy to receive a refund and ensure the subpotent medication is properly handled.
Healthcare facilities or providers with questions can contact SCA Pharmaceuticals directly at 877-550-5059.
For additional information or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall refund and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (10 mg/mL) 0.25 mL

Model:

D-0918-2018

Lot Numbers:

20180507@21 (Exp 7/1/2018)

20180511@9 (Exp 7/5/2018)

20180511@24 (Exp 7/5/2018)

20180518@24 (Exp 7/12/2018)

20180518@31 (Exp 7/12/2018)

20180518@32 (Exp 7/12/2018)

20180531@21 (Exp 7/25/2018)

20180601@11 (Exp 7/26/2018)

20180507

Date Ranges: Expiration dates between 7/1/2018 and 7/26/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80425

Status: Resolved

Manufacturer: SCA Pharmaceuticals

Sold By: Hospitals; Clinics; Pharmacies

Manufactured In: United States

Units Affected: 3984 syringes

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Buffered Lidocaine 1% with Sodium Bicarbonate Injection (10 mg/mL) 0.25 mL syringes by checking the lot numbers and expiration dates on the packaging.

Locate the following specific lot numbers and expiration dates: Lot 20180507@21 (Exp 7/1/2018); Lots 20180511@9 and 20180511@24 (Exp 7/5/2018); Lots 20180518@24, 20180518@31, and 20180518@32 (Exp 7/12/2018); Lot 20180531@21 (Exp 7/25/2018); and Lot 20180601@11 (Exp 7/26/2018).

Immediately stop using any product from these identified lots and contact your pharmacist or healthcare provider for guidance on returning the medication.

Return any unused syringes to the place of purchase or pharmacy to receive a refund and ensure the subpotent medication is properly handled.

Healthcare facilities or providers with questions can contact SCA Pharmaceuticals directly at 877-550-5059.

For additional information or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (10 mg/mL) 0.25 mL

Model:

D-0918-2018

Lot Numbers:

20180507@21 (Exp 7/1/2018)

20180511@9 (Exp 7/5/2018)

20180511@24 (Exp 7/5/2018)

20180518@24 (Exp 7/12/2018)

20180518@31 (Exp 7/12/2018)

20180518@32 (Exp 7/12/2018)

20180531@21 (Exp 7/25/2018)

20180601@11 (Exp 7/26/2018)

20180507

Date Ranges: Expiration dates between 7/1/2018 and 7/26/2018