Home / Recalls / AAA Pharmaceutical, Inc. / D-0646-2020

D-0646-2020 Class II Terminated

Recalled by AAA Pharmaceutical, Inc. — Lumberton, NJ

Recall Details

Product Type: Drugs
Report Date: January 15, 2020
Initiation Date: December 26, 2019
Termination Date: March 10, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 31,536 (130-count bottles)

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

Distribution Pattern

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