FDA-Drug2020-03-18Class II
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
Precision Dose Inc.
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Sold states
Nationwide USA
Affected count
224,940 unit dose cups
Manufactured in
722 Progressive Ln, South Beloit, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1004-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief