FDA recall D-1057-2017
PD-Rx Pharmaceuticals, Inc. · Class II · drug
Product
Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
Reason for recall
Failed Tablet/Capsule Specification: out of specification for tablet weight.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-07-28
- Report date
- 2017-08-09
- Termination date
- 2017-12-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Oklahoma City, OK, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1057-2017