FDA recall D-0797-2020

Product

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)

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-0797-2020