Diclofenac Sodium Topical Solution Recalled

Defective containers have prompted Ingenus Pharmaceuticals to recall 29,435 bottles of diclofenac sodium topical solution, 1.5% w/w. According to the April 3, 2019, US Food and Drug Administration (FDA) Enforcement Report, customers have reported leaky bottles. 

The recall affects diclofenac sodium topical solution in 5-ounce (150-mL) bottles (NDC 50742-308-05) from the following lots: 31804 (Exp. 11/19); 31911 and 31917 (Exp. 2/20); 32067, 32072, and 32084 (Exp. 6/20); and 32248 (Exp. 10/20). The recalled bottles were distributed throughout the United States and in Puerto Rico. 

Ingenus Pharmaceuticals voluntarily initiated the recall March 18, 2019. The FDA designated it Class III on March 25, 2019. Under the recall classification, use of the affected solution is not likely to cause harm.

Diclofenac sodium topical solution is a prescription nonsteroidal anti-inflammatory drug (NSAID) used to treat osteoarthritis of the knee. 

—Jolynn Tumolo