FDA Recall D-0093-2022
MERCK SHARP & DOHME CORP · Whitehouse Station, NJ
Class I — life-threatening Terminated 644 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0093-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide within the United States
- Recall initiated
- 2021-10-19
- Classified by FDA Center
- 2021-11-03
- FDA published
- 2021-11-10
- Terminated
- 2023-07-25
- Recalling firm
- MERCK SHARP & DOHME CORP
- Firm location
- Whitehouse Station, NJ