Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in…
Reason cGMP deviations
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
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
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.
Reason cGMP deviations
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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