FDA recall D-0315-2020

Apotex Inc. · Class II · drug

Product

Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015

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-0315-2020