Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Urgent Drug Recall of Ranitidine Tablet 300mg, and Ranitidine Syrup 15 mg


URGENT: VOLUNTARY DRUG RECALL EXTENDED

Description NDC No. Lot Expiration Date
Ranitidine Syrup 15mg/mL 65162066490 06648001A 11/1/2019
Ranitidine Syrup 15mg/mL 65162066490 06648003A 4/1/2020
Ranitidine Syrup 15mg/mL 65162066490 06649001A 1/1/2021
Ranitidine Tab 300mg 53746025402 HB04118A 2/1/2020
Ranitidine Tab 300mg 53746025402 HB04218A 2/1/2020
Ranitidine Tab 300mg 53746025402 HB04318A 2/1/2020
Ranitidine Tab 300mg 53746025402 HB04418A 2/1/2020
Ranitidine Tab 300mg 53746025402 HF13518A 6/1/2020
Ranitidine Tab 300mg 53746025402 HF13618A 6/1/2020
Ranitidine Tab 300mg 53746025402 HF13718A 6/1/2020
Ranitidine Tab 300mg 53746025402 HF13818A 6/1/2020
Ranitidine Tab 300mg 53746025402 HK02818A 9/1/2020
Ranitidine Tab 300mg 53746025402 HK02918A 9/1/2020
Ranitidine Tab 300mg 53746025402 HK03018A 9/1/2020
Ranitidine Tab 300mg 53746025402 HK03118A 9/1/2020
Ranitidine Tab 300mg 53746025402 HL08418A 11/1/2020
Ranitidine Tab 300mg 53746025402 HL08518A 11/1/2020
Ranitidine Tab 300mg 53746025402 HL08618A 11/1/2020
Ranitidine Tab 300mg 53746025402 HL08718A 11/1/2020
Ranitidine Tab 300mg 53746025402 HB01419A 1/1/2021
Ranitidine Tab 300mg 53746025402 HB05619A 1/1/2021
Ranitidine Tab 300mg 53746025402 HB05719A 1/1/2021
Ranitidine Tab 300mg 53746025402 HB05819A 1/1/2021
Ranitidine Tab 300mg 53746025402 HB05919A 1/1/2021
Ranitidine Tab 300mg 53746025402 HB06019A 1/1/2021
Ranitidine Tab 300mg 53746025402 HB06119A 1/1/2021

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Extended Recall of Ranitidine Tablets 300mg, and Ranitidine Syrup 15 mg/mL to the consumer level. The recall is due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity.A listing of the NDC numbers and impacted lot numbers are indentified. Affected product started shipping August 2018.

Consumers should contact their physician or health care provider if they have experienced any problems that my be related to the use of this drug.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Contact:

Amneal Pharmaceuticals: Amneal Stericycle 866-918-8768