Class II · Moderate risk Ongoing
Phentermine Hydrochloride Capsules
Reason cGMP deviations
Phentermine Capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
What was recalled
Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- NDC code
- 55289-791-07
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1118-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Phentermine recalls
See all
Class II · Moderate risk Terminated
Phentermine HCL 37.5mg 100 C4
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Phentermine HCL 30mg 100 C4
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Phentermine
Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk Terminated
Phentermine HCL Blue Speckled tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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