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
D-0093-2022
Product summary
- Event
- Event 88867
- Status
- Terminated
- Classification
- Class I
- Quantity
- 76,163 vials
- Official record key
drug-enforcement:D-0093-2022
Official wording
Reason: Presence of Particulate Matter: Identified as Glass Particles
Code information: Lot #: 934778, Exp. Date Jun 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter