RecallDepth
Class II Terminated

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

Company
Aaa Pharmaceutical, Inc.
Recall Initiated
December 26, 2019
Posted
January 15, 2020
Recall Number
D-0645-2020
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
34,272 (24-count bottles)
Firm Location
Lumberton, NJ, United States

Reason for Recall

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

Distribution

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

Lot / Code Info

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

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