Class II · Moderate risk Ongoing
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in…
Reason cGMP deviations
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
What was recalled
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
- Recalling firm
- Aidarex Pharmaceuticals LLC
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1162-2017
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; NDC/UPC 10702002901; RX; CAPSULES
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company…
Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk Terminated
Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC…
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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