D-1484-2020 Class I Terminated

Recalled by Mylan Institutional LLC — Rockford, IL

FDA drug recall D-1484-2020 was initiated by Mylan Institutional LLC on Jul 7, 2020 and is designated Class I. Reason for recall: Presence of Particulate Matter The recall status is terminated (terminated Jan 27, 2023). Affected quantity: 18,480 vials.

Recall Details

Product Type
Drugs
Report Date
Aug 12, 2020
Initiation Date
Jul 7, 2020
Termination Date
Jan 27, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,480 vials

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

Reason for Recall

Presence of Particulate Matter

Distribution Pattern

USA Nationwide

Code Information

Lot #: 7605112, Exp 10/2021

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1484-2020
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-1484-2020. Report a data issue: hello@regdatalab.com.