Medications & Supplements/Prescription Drugs

Pacira Pharmaceuticals, Inc.: EXPAREL (bupivacaine liposome) Recalled for Sub-Potency

Agency Publication Date: December 5, 2019

Summary

Pacira Pharmaceuticals, Inc. is recalling 910 vials of EXPAREL (bupivacaine liposome injectable suspension) 20 mL vials. This prescription medication is being recalled because testing showed the drug was sub-potent, meaning it fell below the required strength specifications. Using a sub-potent medication may result in inadequate pain management for patients following surgical procedures. Consumers should contact their healthcare provider or pharmacist if they have concerns about a recent treatment involving this product.

Risk

The drug is sub-potent and out of specification, which means patients may not receive the intended dose of pain medication. This can lead to a failure in managing post-surgical pain and may require additional medical intervention or alternative treatments.

What You Should Do

Check your medication records or vial labels for EXPAREL (bupivacaine liposome) 1.3%, 266 mg/20 mL (13 mg/mL) in 20 mL sterile vials.
Identify if you have products from Pacira Lot number 19-5002 or Patheon manufacturer Lot number 098214, both with an expiration date of December 2019.
Verify the National Drug Code (NDC) on the packaging is 65250-266-20 and the recall number is D-0621-2020.
Contact your healthcare provider or pharmacist immediately for guidance if you believe you have used or possess this sub-potent medication.
Return any unused vials from these specific lots to your pharmacy or the place of purchase for a refund.
Contact Pacira Pharmaceuticals, Inc. at their San Diego office for further instructions regarding this voluntary recall.
For additional questions or to report a complaint, 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

Return unused product for a refund.

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

Affected Products

Product: EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile (20 mL vial)

Model:

NDC: 65250-266-20

Recall #: D-0621-2020

Lot Numbers:

19-5002 (Exp. Dec 2019)

098214 (Exp. Dec 2019)

Date Ranges: December 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84311

Status: Resolved

Manufacturer: Pacira Pharmaceuticals, Inc.

Sold By: Hospitals; Surgical Centers; Healthcare Providers

Manufactured In: United States

Units Affected: 910 20 mL vials

Distributed To: Nationwide

Agency Last Updated: December 10, 2019

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

Check your medication records or vial labels for EXPAREL (bupivacaine liposome) 1.3%, 266 mg/20 mL (13 mg/mL) in 20 mL sterile vials.

Identify if you have products from Pacira Lot number 19-5002 or Patheon manufacturer Lot number 098214, both with an expiration date of December 2019.

Verify the National Drug Code (NDC) on the packaging is 65250-266-20 and the recall number is D-0621-2020.

Contact your healthcare provider or pharmacist immediately for guidance if you believe you have used or possess this sub-potent medication.

Return any unused vials from these specific lots to your pharmacy or the place of purchase for a refund.

Contact Pacira Pharmaceuticals, Inc. at their San Diego office for further instructions regarding this voluntary recall.

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