Recalls / Class II
Class IID-0315-2020
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
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, N/A, North York, N/A N/A, Canada
Distribution
- Quantity
- 42,873 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-09-24
- FDA classified
- 2019-11-12
- Posted by FDA
- 2019-11-20
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0315-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.