Home / Recalls / Amneal Pharmaceuticals, Inc. / D-0616-2020

D-0616-2020 Class II Ongoing

Recalled by Amneal Pharmaceuticals, Inc. — Brookhaven, NY

Recall Details

Product Type
Drugs
Report Date
December 18, 2019
Initiation Date
November 22, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

Reason for Recall

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

Distribution Pattern

Product was distributed throughout the United States.

Code Information

HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021

Other recalls by Amneal Pharmaceuticals, Inc.

  • D-0619-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Ma (August 18, 2025)
  • D-0615-2025 Class II — Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx (August 18, 2025)
  • D-0616-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Ma (August 18, 2025)
  • D-0617-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Man (August 18, 2025)
  • D-0618-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, M (August 18, 2025)
  • D-0488-2025 Class I — Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Ta (June 2, 2025)
  • D-0402-2025 Class I — Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manu (April 17, 2025)
  • D-0629-2024 Class III — Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amn (August 1, 2024)
  • D-0612-2020 Class II — Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100- (November 22, 2019)
  • D-0613-2020 Class II — Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100- (November 22, 2019)