NSAID Recalled

Defective containers prompted Teligent Pharma Inc to voluntarily recall three lots of diclofenac sodium topical solution, according to the December 1, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed throughout the United States:

• diclofenac sodium topical solution, 1.5 w/w, 5 fl oz (150 mL), in plastic bottles (NDC 52665-002-05) from lot 15188 (Exp. 2/23); and
• diclofenac sodium topical solution, 1.5 w/w, 5 fl oz (150 mL), in plastic bottles (NDC 52665-025-05) from lots 15028 (Exp. 1/23) and 15379 (Exp. 3/23).

Teligent Pharma Inc initiated the recall October 19, 2021. The FDA designated the recall Class II on November 23, 2021, communicating use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Diclofenac sodium topical solution is a prescription nonsteroidal anti-inflammatory drug used to relieve pain, inflammation, and joint stiffness caused by arthritis.