Manufacturer Perrigo Pharmaceuticals has issued a voluntary recall for clindamycin/benzoyl peroxide gel (1.2%/5%), a topical medication used to treat acne.
This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled their clindamycin/benzoyl peroxide gel products, with the knowledge of the FDA.
Why was clindamycin/benzoyl peroxide gel recalled?
Perrigo Pharmaceuticals has voluntarily recalled their clindamycin/benzoyl peroxide (1.2%/5%) gel, due to the presence of a small amount of mold on the caps of the tubes. Clindamycin/benzoyl peroxide is the generic for the brand name drug Duac, which has not been affected by this recall.
The mold in the caps can present a risk for infection, especially in immunocompromised patients whose immune system can’t fight bacteria and mold.
Which products were recalled?
In this recall, the following lots of clindamycin/benzoyl peroxide (1.2%/5%) 45 gram tubes were affected:
#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)
Have any other manufacturer’s been affected?
No. At this time only Perrigo Pharmaceuticals clindamycin/benzoyl peroxide gel has been recalled.
How can I find more information from the manufacturer?
The manufacturer, Perrigo Pharmaceuticals, can be reached by calling their toll-free recall phone number at 1-800-321-0105, or by visiting their website here.
Are patients who have taken this medication being notified?
No. This is a class II recall, which means that it isn’t necessary to notify you unless your doctor believes it may have a effect on your health. However, pharmacies with the affected lot in their inventory have been directed to stop distribution and arrange for product return.
If you have concerns that your prescription may be affected, contact your doctor for more information.