Drug product
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
D-0285-2018
Product summary
- Event
- Event 78575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3800 cases
- Official record key
drug-enforcement:D-0285-2018
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: DYNDR1111; Lots: 17FB1191; 17HB1905 Pack Number: DYNDR1112A; Lots 177B0660; 175B2485
Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Derived failure modes
-
Potency or specification failure
Subpotent