FDA recall D-0317-2020

Product

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011

Reason for recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Distribution

Nationwide

Key facts

Status

Completed

Initiation date

2019-09-24

Report date

2019-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

North York, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0317-2020