Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Daptomycin for Injection 350 mg/vial Recalled by Accord Healthcare, Inc. Due to CGMP Deviations: recalling drug products following an FDA...

Date: February 7, 2023
Company: Accord Healthcare, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Accord Healthcare, Inc. directly.

Affected Products

Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45 UPC 3 16729 43445 4 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Quantity: 65,233 vials

Why Was This Recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

Where Was This Sold?

United States including Puerto Rico and Canada

About Accord Healthcare, Inc.

Accord Healthcare, Inc. has 76 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report