Drug product
Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
D-0294-2018
Product summary
- Event
- Event 78575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,250 cases
- Official record key
drug-enforcement:D-0294-2018
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: DYNDS1010; Lots 15EB9408
Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Derived failure modes
-
Potency or specification failure
Subpotent