Recalls / Class II
Class IID-0559-2016
Product
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
- Affected lot / code info
- Lot# B14D26, Exp 02/16
Why it was recalled
cGMP Deviations
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
- 9 bottles
- Distribution pattern
- Alabama
Timeline
- Recall initiated
- 2015-07-10
- FDA classified
- 2015-12-31
- Posted by FDA
- 2016-01-06
- Terminated
- 2017-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0559-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.