Recalls / Class II
Class IID-0316-2020
Product
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
- 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
- 1,132,453 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-0316-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.