Drug product

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

D-0307-2018

September 21, 2017

Class II

Product summary

Firm: Medline Industries Inc
Event: Event 78575
Status: Terminated
Classification: Class II
Quantity: 49,587 cases
Official record key: drug-enforcement:D-0307-2018

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: MDS701550; Lots 16GB7687; 17HB5153; 16IB0427; 17GB3906; 17AB1937; 17CB7737; 16JB1136; 16JB1137 Pack Number: MDS701550H; Lots 16QB4583; 16IB0427; 17CB7737; 16MB6165; 17GB3906; 17AB1937; 16GB7687; 16JB1137; 17HB5153

Distribution pattern: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Subpotent