Drug product
Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
D-0264-2018
Product summary
- Event
- Event 78575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65,563 cases
- Official record key
drug-enforcement:D-0264-2018
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: DYND70900; Lots: 17GB6098; 16KB8714; 17GB5103; 17EB4268; 17BB3409; 17SB1821; 17OB8226; 16QB7895; 17EB7214; 16LB5336; 17QB4767; 17MB3722; 17PB7167; 17EB0363; 17DB2103; 17FB2572 Pack Number: DYND70900H; Lots: 16KB8714; 16KB8714; 17EB4268; 17OB8226; 17OB8226; 17EB0363; 17EB0363; 17EB4268; 17EB4268; 16WB5947; 17GB6098; 17GB6098; 17QB4767; 17QB4767; 17MB3722; 17MB3722; 16SB7791; 16TB0404; 17GB6098; 17EB7214; 17EB0363; 17BB3409; 17PB7167; 17PB7167; 17EB7214; 17GB6098; 17PB7167; 17PB7167; 17EB4268; 17EB0363; 17PB7167; 17QB4767; 17QB4767; 17QB4767; 17EB7214; 17EB7214; 17OB8226; 17QB4767; 17BB3409; 17EB7214; 17QB4767; 17QB4767; 17QB4767; 17GB6098; 17GB6098; 17PB7167; 16TB0404; 17PB7167; 17QB4767; 17QB4767; 16WB5947; 17BB3409
Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Derived failure modes
-
Potency or specification failure
Subpotent