Tolmar Inc. is initiating a voluntary recall of three (3) lots of CLINDAMYCIN AND BENZOYL PEROXIDE GEL, distributed by Sandoz Inc. This recall has been initiated because stability testing has found lot 11557C1 to be Out of Specification (OOS) based upon Tolmar’s stability testing of the lot obtained at the 12-month timepoint for clindamycin phosphate in the reconstituted product. The adverse skin reaction would likely initially present as irritant contact dermatitis that would likely be noticeable by users prior to becoming a serious medical problem. As this is a topical product, the risk is considered low from a medical perspective.
This recall is to the Retail Level, and is only for the lots specified in the notification.
Here’s a full lot list and more information about the recall.
Here’s a return letter to fill out if you ordered the products from PBA Health since October 2020. Any pharmacy with affected product should contact Sedgwick for a return kit.