Drug Recall Notices

Below are recent prescription drug/device recall notices provided to the Board by the FDA (Food & Drug Administration).

• FDA has updated their web posting regarding the investigation of Burkholderia cepacia complex (Bcc) infections associated with Medline Remedy® Essentials No-Rinse Foam manufactured by Shadow Holdings dba Bocchi Laboratories.
  Shadow Holdings dba Bocchi Laboratories has issued a voluntary recall expanding the recall initially issued on March 28, 2018 to include:
  
  1. An additional master lot of the Medline Remedy® Essentials No-Rinse Foam. The expanded recall includes lot M07476 in addition to previous recalled lots M05703, M06691, and M07247.
  
  2. Medline Remedy® Essentials No-Rinse Foam 4 ounce bottles from the M05703 master lot. The initial recall only included 8 oz bottles from this lot.
  
  3. Additional cosmetic products
  
  4. Over the counter medications
  
  For a complete list of the cosmetic products and lot numbers that have been recalled including the lots of the Medline Remedy® Essentials No-Rinse Foam follow the below instructions:
  
  1. Go to https://www.accessdata.fda.gov/scripts/ires/index.cfm
  
  2. Click on the Advanced Search tab.
  
  3. Type “Shadow Holdings” into the Recalling Firm and click Search
  
  For a complete list of over the counter medications that have been recalled by Shadow Holdings go to: https://www.fda.gov/Safety/Recalls/ucm609003.htm
  CDC continues to work with FDA and state and local health departments in affected states to investigate this outbreak. Healthcare facilities should follow the guidance provided by FDA while further investigation is being conducted and facilities with recalled product should follow the instructions provided by the manufacturer in the recall notice.