OXYCODONE AND ACETAMINOPHEN
Generic: OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
SpecGx LLCManufacturer
ORALRoute
OXYCODONE HYDROCHLORIDEActive Substance
2004-06-30Original Approval
OXYCODONE AND ACETAMINOPHEN is FDA application ANDA040545, sponsored by SPECGX LLC. 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 II2025-12-16
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II2025-12-16
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II2020-03-18
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA,CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Top Reported Reactions
1
PAIN
1,500 reports
2
FATIGUE
1,444 reports
3
DRUG INEFFECTIVE
1,427 reports
4
DYSPNOEA
1,064 reports
5
NAUSEA
992 reports
6
ARTHRALGIA
974 reports
7
HEADACHE
909 reports
8
RASH
876 reports
9
PRURITUS
857 reports
10
PYREXIA
828 reports