FDA-Drug2015-09-02Class III
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
KVK-Tech, Inc.
Hazard
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Sold states
Nationwide
Affected count
9,696 bottles (100-count), 972 bottles (1000-count)
Manufactured in
110 Terry Dr, N/A, Newtown, PA, United States
Products
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1371-2015Don't want to check this manually?
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