FDA recall D-0319-2020

Product

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8

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-0319-2020