Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
FDA Recall #D-0646-2020 — Class II — December 26, 2019
Product Description
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
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
31,536 (130-count bottles)
Distribution
Product was distributed to one consignee who may have distributed the product further to their retail stores.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated