Allergan issued a voluntary recall of two lots of Tazorac (tazarotene) Gel 0.05% due to routine stability results for one lot that were slightly below regulatory specifications for Product Concentration and Content Uniformity.
Other test parameters were within specification but because the second lot was filled from the same bulk batch, both lots are being recalled as a precautionary measure. Currently, no adverse reactions have been reported for this issue or similar situations. Patient safety risk is considered to be minimal relative to product concentration and content uniformity being slightly below regulatory specifications. The Company reported that adverse effects are not likely to occur and noticeable impact on efficacy and safety profile is not anticipated.
The affected products have Lot #84172 (30g tube) and #84173 (100g tube). The 30g tubes were distributed between 7/29/14-12/18/14 and the 100g tubes were distributed between 4/30/14- 8/13/14; both products have an expiration date of February 2017. Anyone in possession of the recalled product lots are to stop distribution and quarantine the affected inventory.
For more information call (800) 433-8871 or visit Tazorac.com.