Preferred Pharmaceuticals recalled over manufacturing violations

Recall date

January 7, 2020

Source

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

Official notice title

Preferred Pharmaceuticals, Inc recalls Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottle…

Recall number

D-0796-2020

FDA classification

Class II

Brand / firm

Preferred Pharmaceuticals, Inc

Sold / distributed

Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

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

What was recalled

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)