Muscle Relaxant Recall Spans Three Labelers

Deviations from Current Good Manufacturing Practice regulations have prompted the recall of more than 19,000 bottles of cyclobenzaprine hydrochloride tablets from three labelers: Teva Pharmaceuticals, Casper Pharma, and Rising Health.

According to the September 8, 2021, US Food and Drug Administration (FDA) Enforcement Report, the recall was prompted by an “out of specification (OOS) test result for total aerobic microbial count (TAMC) and total yeast and mold count (TYMC) for an excipient batch of dibasic calcium phosphate.”

The recall affects the following products, which were manufactured by Actavis Laboratories, Fort Lauderdale, FL, and distributed throughout the United States:

• 100-count bottles of cyclobenzaprine hydrochloride tablets, 7.5 mg (NDC 0591-3330-01), labeled by Teva Pharmaceuticals, from lot 1408821A (Exp. 8/23);
• 100-count bottles of cyclobenzaprine hydrochloride tablets, 7.5 mg (NDC 57237-266-01), labeled by Rising Health, from lot 1408824A (Exp. 8/23); and
• 100-count bottles of cyclobenzaprine hydrochloride tablets, 7.5 mg (NDC 70199-014-01), labeled by Caper Pharma, from lot 1408822A (Exp. 8/23).

Teva Pharmaceuticals initiated the voluntary recalls July 29, 2021. On August 27, 2021, the FDA designated them Class II, signaling use of the tablets could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Cyclobenzaprine hydrochloride is a prescription muscle relaxant used to relieve pain from muscle injuries.