D-0302-2018 Class II Terminated
FDA drug recall D-0302-2018 was initiated by Medline Industries Inc on September 21, 2017 and is designated Class II. Reason for recall: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. The recall status is terminated (terminated August 28, 2023). Affected quantity: 2,369 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2018
- Initiation Date
- September 21, 2017
- Termination Date
- August 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,369 cases
Product Description
Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
Reason for Recall
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Distribution Pattern
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Code Information
Pack Number: DYNJ07147; Lots 1160B1635; 17RB8957; 16WB2198; 16GB6023; 16KB1547; 17DB1855 Pack Number: DYNJ07147H; Lots 17DB1855; 16WB2198; 17RB8957