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, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 cou…

Recall number

D-0797-2020

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, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)