FDA recall D-0674-2017
InnovaGel · Class III · drug
Product
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284
Reason for recall
Subpotent
Distribution
NY only
Key facts
- Status
- Terminated
- Initiation date
- 2017-01-05
- Report date
- 2017-04-26
- Termination date
- 2021-09-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Miami, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0674-2017