Recalls / Class II
Class IID-1057-2017
Product
Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
- Affected lot / code info
- Lot: A17F55 Exp. 06/30/2018
Why it was recalled
Failed Tablet/Capsule Specification: out of specification for tablet weight.
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, N/A, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 100 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-07-28
- FDA classified
- 2017-08-03
- Posted by FDA
- 2017-08-09
- Terminated
- 2017-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1057-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.