Home / Recalls / AAA Pharmaceutical, Inc. / D-0645-2020

D-0645-2020 Class II Terminated

Recalled by AAA Pharmaceutical, Inc. — Lumberton, NJ

FDA drug recall D-0645-2020 was initiated by AAA Pharmaceutical, Inc. on December 26, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API The recall status is terminated (terminated March 10, 2021). Affected quantity: 34,272 (24-count bottles).

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
34,272 (24-count bottles)

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

Distribution Pattern

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

Other recalls by AAA Pharmaceutical, Inc.

  • D-0868-2020 Class III — Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg / (February 14, 2020)
  • D-0646-2020 Class II — Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. (December 26, 2019)
  • D-1585-2019 Class III — Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC (June 25, 2019)

FDA data resources