PlainRecalls
FDA Drug Critical Class I Terminated

Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01

Reported: November 10, 2021 Initiated: October 19, 2021 #D-0093-2022

Product Description

Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01

Reason for Recall

Presence of Particulate Matter: Identified as Glass Particles

Details

Recalling Firm
MERCK SHARP & DOHME CORP
Units Affected
76,163 vials
Distribution
Nationwide within the United States
Location
Whitehouse Station, NJ

Frequently Asked Questions

What product was recalled?
Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01. Recalled by MERCK SHARP & DOHME CORP. Units affected: 76,163 vials.
Why was this product recalled?
Presence of Particulate Matter: Identified as Glass Particles
Which agency issued this recall?
This recall was issued by the FDA Drug on November 10, 2021. Severity: Critical. Recall number: D-0093-2022.