PENICILLIN V POTASSIUM
Generic: PENICILLIN V POTASSIUM
Hikma Pharmaceuticals USA Inc.Manufacturer
ORALRoute
PENICILLIN V POTASSIUMActive Substance
2013-10-11Original Approval
PENICILLIN V POTASSIUM is FDA application ANDA090549, sponsored by HIKMA PHARMS. 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 III2017-02-24
Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLPresence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassiu
Class III2017-11-28
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, ManufacFailed Impurities/Degradation Specifications: high out of specification test results obtained for in
Class II2021-03-15
PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
DRUG HYPERSENSITIVITY
467 reports
2
DYSPNOEA
220 reports
3
ANXIETY
180 reports
4
HYPERSENSITIVITY
155 reports
5
CONDITION AGGRAVATED
148 reports
6
ASTHMA
146 reports
7
FATIGUE
142 reports
8
RASH
136 reports
9
OFF LABEL USE
124 reports
10
PAIN IN EXTREMITY
123 reports