FDA recall D-0314-2020

Product

Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06

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-0314-2020