Muscle Relaxants Recalled

Two firms issued recalls for tizanidine tablets after the product’s manufacturer, Dr Reddy’s Laboratories, recalled the tablets for failing to meet stability specifications, according to the July 12, 2023, US Food and Drug Administration (FDA) Enforcement Report.

On June 23, 2023, Amerisource Health Services recalled nearly 5000 cartons of tizanidine tablets, 4 mg, 100 tablets per carton (10 tablets x 10 unit dose blister packs; carton NDC 68084-645-01, barcode [01] 003 68084 645 11 2), from lot 1004835 (Exp. 7/31/23). The product was packaged and distributed throughout the United States by American Health Packaging, Columbus, Ohio.

On June 26, 2023, Preferred Pharmaceuticals Inc. recalled 541 bottles of tizanidine hydrochloride tablets, 4 mg, distributed throughout the United States and packaged in:

• 20 count-bottles (NDC 68788-7781-2), from lot H1621S (Exp. 12/31/23);
• 30-count bottles (NDC 68788-7781-3), from lot H2321C (Exp. 12/31/23);
• 60-count bottles (NDC 68788-7781-6), from lot H0421B (Exp. 12/31/23);
• 90-count bottles (NDC 68788-7781-9), from lots H1721E, H1921T, and H3121M (Exp. 12/31/23); and
• 120-count bottles (NDC 68788-7781-8), from lot H2021G (Exp. 12/31/23).

The FDA designated both recalls Class II. The designation communicates that use of the affected drug could cause temporary or medically reversible adverse health consequences. Although remote, the possibility of serious harm also exists.

Tizanidine is a prescription skeletal muscle relaxant indicated for the management of spasticity.