Drug product
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
D-0309-2018
Product summary
- Event
- Event 78575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98,901 cases
- Official record key
drug-enforcement:D-0309-2018
Official wording
Reason: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
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
Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Derived failure modes
-
Potency or specification failure
Subpotent