Recalls

Mold found on acne gel caps prompts recall

acne 435x296 Mold found on acne gel caps prompts recallSeveral tubes of a generic Duac acne gel are being recalled by maker Perrigo because a small amount of mold was found on tubes’ caps. The mold poses a slight risk of infection to users, especially those with compromised immune systems. No adverse events have been reported to date.

The recall affects 10 lots of Clindamycin Phosphate and Benzoyl Peroxide Gel (1.2%/5%) in 45g tubes with the following lot numbers and expiration dates:

  • #080806 (Exp 12/16)
  • #080844 (Exp 12/16)
  • #080963 (Exp 12/16)
  • #080999 (Exp 12/16)
  • #084109 (Exp 03/17)
  • #084197 (Exp 03/17)
  • #091090 (Exp 10/17)
  • #092319 (Exp 11/17)
  • #092399 (Exp 12/17)
  • #092440 (Exp 12/17)

The recalled acne gel is indicated for the topical treatment of inflammatory acne vulgaris. The clindamycin and benzoyl peroxide components are used to fight the organism Propionibacterium acnes, which is associated with acne vulgarism.

The company has called for its distributors to quarantine any affected tubes of the product and remove it from distribution. Any side effects related to this acne gel should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: MPR