Recalls / Class III
Class IIID-0574-2016
Product
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.
- Brand name
- Phentermine Hydrochloride
- Generic name
- Phentermine Hydrochloride
- Active ingredient
- Phentermine Hydrochloride
- Route
- Oral
- NDC
- 55289-791
- FDA application
- ANDA040886
- Affected lot / code info
- Lot #: a) H14C80, Exp 08/16; I14G36, Exp 09/16; b) H14A86, Exp 07/16; c) H14C83, Exp 08/16, K14A21, Exp 11/16; d) H14F25, Exp 08/16; e) L14C42, Exp 12/16.
Why it was recalled
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
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
- 1685 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-21
- FDA classified
- 2016-01-20
- Posted by FDA
- 2016-01-27
- Terminated
- 2016-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0574-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.