Drug product
Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
D-0302-2018
Product summary
- Event
- Event 78575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,369 cases
- Official record key
drug-enforcement:D-0302-2018
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: DYNJ07147; Lots 1160B1635; 17RB8957; 16WB2198; 16GB6023; 16KB1547; 17DB1855 Pack Number: DYNJ07147H; Lots 17DB1855; 16WB2198; 17RB8957
Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Derived failure modes
-
Potency or specification failure
Subpotent