Drug recall D-0646-2020

Class II Terminated reported Jan 15, 2020

Product

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

Reason for recall

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

Lots and codes

P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021

Recall details

Recalling firm
AAA Pharmaceutical, Inc., Lumberton, NJ
Quantity
31,536 (130-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