Drug product

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

D-0645-2020

December 26, 2019

Class II

Product summary

Firm: AAA Pharmaceutical, Inc.
Event: Event 84583
Status: Terminated
Classification: Class II
Quantity: 34,272 (24-count bottles)
Official record key: drug-enforcement:D-0645-2020

Official wording

Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Code information: P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021

Distribution pattern: Product was distributed to one consignee who may have distributed the product further to their retail stores.

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

Impurity N-nitrosodimethylamine (NDMA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations