PHENTERMINE HYDROCHLORIDE
Generic: PHENTERMINE HYDROCHLORIDE
TAGI PharmaManufacturer
ORALRoute
PHENTERMINE HYDROCHLORIDEActive Substance
2011-01-31Original Approval
PHENTERMINE HYDROCHLORIDE is FDA application ANDA200272, sponsored by ELITE LABS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class III2017-08-03
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDCFailed Impurities/Degradation Specifications: out-of-specification results obtained for individual u
Class III2017-08-11
Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count Failed Impurities/Degradation Specifications:Out of specification results for individual unknown imp
Class II2025-05-09
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, MacGMP deviations
Class III2015-07-21
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-1Failed impurities/Degradation specifications: out of specification results for individual unknown an
Top Reported Reactions
1
DRUG INEFFECTIVE
182 reports
2
FATIGUE
72 reports
3
PAIN
72 reports
4
HEADACHE
63 reports
5
ARTHRALGIA
49 reports
6
NAUSEA
44 reports
7
PRODUCT DOSE OMISSION ISSUE
42 reports
8
ANXIETY
40 reports
9
PRURITUS
37 reports
10
DYSPNOEA
32 reports