D-1118-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 12, 2014
- Initiation Date
- November 1, 2013
- Termination Date
- April 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25%
Reason for Recall
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Distribution Pattern
NC
Code Information
All lot numbers within expiry.