Drug product
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
D-0318-2018
Product summary
- Event
- Event 78575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,495 cases
- Official record key
drug-enforcement:D-0318-2018
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: Z302-R; Lots 177B2075; 17RB9452; 17QB2640; 17CB4220 Pack Number: Z302-RH; Lots 177B2075; 17QB2640; 17RB9452; 17CB4220; 17NB1933; 17MB0084; 16LB3367
Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Derived failure modes
-
Potency or specification failure
Subpotent