FDA recall D-0796-2020

Product

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)

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-01-07

Report date

2020-01-29

Termination date

2023-12-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0796-2020