FDA recall D-0093-2022

MERCK SHARP & DOHME CORP · Class I · drug

Product

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

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2021-10-19
Report date
2021-11-10
Termination date
2023-07-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Whitehouse Station, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0093-2022