Drug product
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
D-0310-2018
Product summary
- Event
- Event 78575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 195,448 cases
- Official record key
drug-enforcement:D-0310-2018
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: MDS708555; Lots 17SB5603; 17PB8319; 177B2065; 17DB2104; 17RB9448; 17RB9451; 17PB8314; 17HB5104; 16XB1090; 17QB0860; 16OB0307; 17DB2777; 16UB2803; Pack Number: MDS708555H; Lots 17PB8319; 173B2496; 16UB2803; 16XB1090; 16SB4453; 16RB1126; 17DB2777; 17QB0860; 16TB8928; 17PB8314; 16IB3745; 17RB9451; 17DB2104; 164B2214; 16KB5659
Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Derived failure modes
-
Potency or specification failure
Subpotent