FDA recall D-0017-2021
Direct Rx · Class II · drug
Product
Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution
FL, GA
Key facts
- Status
- Terminated
- Initiation date
- 2020-01-15
- Report date
- 2020-10-14
- Termination date
- 2020-12-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Dawsonville, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0017-2021