HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Generic: HYDROCODONE BITARTRATE AND ACETAMINOPHEN

KVK-TechManufacturer
ORALRoute
HYDROCODONE BITARTRATEActive Substance
2017-06-21Original Approval

HYDROCODONE BITARTRATE AND ACETAMINOPHEN is FDA application ANDA209037, sponsored by ABHAI 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 II2021-11-19
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber

Product Mix-up

Class III2018-05-24
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel La

Labeling: Missing Label

Top Reported Reactions

1
DRUG DEPENDENCE
33,295 reports
2
OVERDOSE
14,511 reports
3
PAIN
12,050 reports
4
EMOTIONAL DISTRESS
10,842 reports
5
DRUG WITHDRAWAL SYNDROME
5,345 reports
6
ANXIETY
4,203 reports
7
DEATH
3,181 reports
8
DEPRESSION
2,728 reports
9
LEARNING DISABILITY
2,407 reports
10
FOETAL EXPOSURE DURING PREGNANCY
2,312 reports