D-0309-2018 Class II Terminated
FDA drug recall D-0309-2018 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: 98,901 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
- 98,901 cases
Product Description
Medline Suture Removal 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: MDS708550; Lots 17GB4997; 17TB7125; 17RB7896; 17HB3784; 17HB4133; 17RB7895; 17FB1724; 17FB2572; Pack Number: MDS708550H; Lots 17GB4997; 17RB7896; 17PB5544; 17FB1724; 16JB1135; 17TB7125; 16SB9345; 17FB2572; 17FB2571; 17RB7895; 17HB3784; 16NB7654; 17FB1721; 16LB8439; 17HB4133; 16WB1269; 16NB8410; 15VB7079