D-1129-2017 Class II Terminated
FDA drug recall D-1129-2017 was initiated by Degasa Sa De Cv on August 4, 2017 and is designated Class II. Reason for recall: Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label. The recall status is terminated (terminated November 24, 2020). Affected quantity: 720 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 13, 2017
- Initiation Date
- August 4, 2017
- Termination Date
- November 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 720 bottles
Product Description
Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09
Reason for Recall
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Distribution Pattern
CA, IL.
Code Information
Lot #: 3A176011, Exp 10/18