FDA recall D-1016-2020
Perrigo Company PLC · Class II · drug
Product
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06
Reason for recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Distribution
Nationwide USA
Key facts
- Status
- Terminated
- Initiation date
- 2019-10-23
- Report date
- 2020-03-25
- Termination date
- 2020-11-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Allegan, MI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1016-2020