Doxycycline Hyclate USP recalled over manufacturing violations

Recall date

June 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

American Pharmaceutical Ingredients LLC recalls Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4),…

Recall number

D-0927-2017

FDA classification

Class II

Brand / firm

American Pharmaceutical Ingredients LLC

Sold / distributed

Nationwide in the US

Why it was recalled

Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327