FDA Recall D-1484-2020
Mylan Institutional LLC · Rockford, IL
Class I — life-threatening Terminated 934 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50
Reason for recall
Presence of Particulate Matter
Recall record
- Recall number
D-1484-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- USA Nationwide
- Recall initiated
- 2020-07-07
- Classified by FDA Center
- 2020-08-04
- FDA published
- 2020-08-12
- Terminated
- 2023-01-27
- Recalling firm
- Mylan Institutional LLC
- Firm location
- Rockford, IL
Drug identification
- Brand name(s)
- DAPTOMYCIN
- Generic name(s)
- DAPTOMYCIN
- Manufacturer(s)
- Mylan Institutional LLC
- NDC(s)
67457-813- Route(s)
- INTRAVENOUS