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)

Recall Number: D-0797-2020

Firm: Preferred Pharmaceuticals, Inc

Classification: Class II

Status: Terminated

Report Date: 20200129

Initiation Date: 20200107

Termination Date: 20231214

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Product Description

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)