Why it was recalled
Presence of Particulate Matter
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 7605112, Exp 10/2021
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1484-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 7, 2020
- FDA report date
- Aug 12, 2020
- Quantity
- 18,480 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional LLC
Original FDA data
Every field from FDA enforcement report D-1484-2020, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 85956
- Address
- 4901 Hiawatha Dr
- Code information
- Lot #: 7605112, Exp 10/2021
- Postal code
- 61103-1287
- Report date
- Aug 12, 2020
- Product type
- Drugs
- Recall number
- D-1484-2020
- Classification
- Class I
- Recalling firm
- Mylan Institutional LLC
- Product quantity
- 18,480 vials
- Termination date
- Jan 27, 2023
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 7, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 4, 2020