D-0311-2018 Class II Terminated
FDA drug recall D-0311-2018 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: 450 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
- 450 cases
Product Description
Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590
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: P524151; Lots 17HB5103; 17RB8741