FDA recall D-0617-2020
Preferred Pharmaceuticals, Inc · Class II · drug
Product
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution
CA, FL
Key facts
- Status
- Terminated
- Initiation date
- 2019-12-02
- Report date
- 2019-12-18
- Termination date
- 2023-05-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Anaheim, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0617-2020