Recalls / Class I
Class ID-0093-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot #: 934778, Exp. Date Jun 2022
Why it was recalled
Presence of Particulate Matter: Identified as Glass Particles
Recalling firm
- Firm
- MERCK SHARP & DOHME CORP
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1 Merck Dr, N/A, Whitehouse Station, New Jersey 08889-3400
Distribution
- Quantity
- 76,163 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-10-19
- FDA classified
- 2021-11-03
- Posted by FDA
- 2021-11-10
- Terminated
- 2023-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0093-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.