D-0282-2018 Class II Terminated
FDA drug recall D-0282-2018 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: 248 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
- 248 cases
Product Description
Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, 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: DYNDR1067; Lots: 17PB4605 Pack Number: DYNDR1067H; Lots: 17PB4605