FDA recall D-0529-2020

Product

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74

Reason for recall

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Distribution

nationwide

Key facts

Status

Ongoing

Initiation date

2019-11-06

Report date

2019-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0529-2020