American Pharmaceutical Ingredients LLC recalls Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6);

Recalled February 28, 2018 · FDA recall D-0481-2018 · American Pharmaceutical Ingredients

Hazard

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. · FDA Class II

Units

123900 g

Sold at

Nationwide within USA.

Description

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Product

Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Manufacturer(s)

American Pharmaceutical Ingredients LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →