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

FDA recall notice · announced November 10, 2021 · Merck Sharp & Dohme

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 934778, Exp. Date Jun 2022
Quantity: 76,163 vials
Status: Terminated
Products in this recall event:
- 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: (D-0093-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.