D-0264-2018 Class II Terminated
FDA drug recall D-0264-2018 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: 65,563 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
- 65,563 cases
Product Description
Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for 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: 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