FDA recall D-1004-2020

Product

Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2019-11-13

Report date

2020-03-18

Termination date

2022-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Beloit, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1004-2020