Bearing expiration dates into 2027.
The oral route isn’t the only method for targeting pain and inflammation, and these days, topical ointments and gels vary well beyond the classic Bengay.
One of these was recently flagged for what sounds to be a subpotent formulation. An FDA report issued on February 6 announced the January 27 “US Nationwide” recall of a topical non-steroidal anti-inflammatory drug in gel form.
The recall affected Diclofenac Sodium, Topical Gel, 3%, in 100-gram dosages. The product appears to be a generic for name-brand Diclofenac sodium 3% products, of which the Cleveland Clinic lists a few examples: DermacinRx Lixofen, DICLOVIX, INFLAMMA-K, PENNSAID, PROFINAC, VOPAC MDS, Xrylix II. It does not appear any of the aforementioned brands are affected.
The Cleveland Clinic also explains that the drug “treats arthritis of the knee” and “works by decreasing inflammation.”
The recalled gel is prescription-only, manufactured by Ontario-based Taro Pharmaceuticals Inc., with a U.S. branch in Hawthorne, NY. The reported national drug code (NDC) for the product is 51372-1363-7. Lot numbers are reported as D92720, AD92721, AD92722, AD92723, all with expiration dates of 03/31/2027.
The FDA cites the recall reason as the following: “This recall has been initiated in response to Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.” In other words, it’s possible a runny consistency didn’t meet quality standards. If this assessment is accurate this could lead to issues with how effectively the product remains on skin and absorbs to provide relief.
A lesser 1% dose of diclofenac sodium is available over the counter in products such as Voltaren pain gel.
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