Drug product
Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
D-0266-2018
Product summary
- Event
- Event 78575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,675 cases
- Official record key
drug-enforcement:D-0266-2018
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: DYND74661; Lots: 177B1602; 17RB9139; 16WB5199; 17CB7720; 17CB5841; 167B0074; 16GB8853; 16JB0621; 17EB4904; 16TB9798; 165B0465 Pack Number: DYND74661H; Lots: 17EB4904; 17CB5841; 17CB1032; 165B0465; 16WB5199; 17RB9139; 17CB7720; 16JB0621; 16TB9798; 177B1602;
Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Derived failure modes
-
Potency or specification failure
Subpotent