Recalls / Class I
Class ID-1484-2020
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
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
- Brand name
- Daptomycin
- Generic name
- Daptomycin
- Active ingredient
- Daptomycin
- Route
- Intravenous
- NDC
- 67457-813
- FDA application
- ANDA205037
- Affected lot / code info
- Lot #: 7605112, Exp 10/2021
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Mylan Institutional LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 4901 Hiawatha Dr, Rockford, Illinois 61103-1287
Distribution
- Quantity
- 18,480 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-07-07
- FDA classified
- 2020-08-04
- Posted by FDA
- 2020-08-12
- Terminated
- 2023-01-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1484-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.