Drug product
Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590
D-0313-2018
Product summary
- Event
- Event 78575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 779 cases
- Official record key
drug-enforcement:D-0313-2018
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: P888899; Lots 17RB8659; 17GB5162 Pack Number: P888899H; Lots 17RB8659
Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Derived failure modes
-
Potency or specification failure
Subpotent