Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
FDA Recall #D-0645-2020 — Class II — December 26, 2019
Product Description
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling Firm
AAA Pharmaceutical, Inc. — Lumberton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
34,272 (24-count bottles)
Distribution
Product was distributed to one consignee who may have distributed the product further to their retail stores.
Code Information
P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated