Drug recall D-0645-2020

Class II Terminated reported Jan 15, 2020

Product

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
AAA Pharmaceutical, Inc., Lumberton, NJ
Quantity
34,272 (24-count bottles)
Distribution
Product was distributed to one consignee who may have distributed the product further to their retail stores.
Type
Voluntary: Firm initiated
Recall initiated
December 26, 2019
Terminated
March 10, 2021