ACETAMINOPHEN AND CODEINE PHOSPHATE

Generic: ACETAMINOPHEN AND CODEINE PHOSPHATE

Strides Pharma Science LimitedManufacturer
ORALRoute
ACETAMINOPHENActive Substance
1988-09-30Original Approval

ACETAMINOPHEN AND CODEINE PHOSPHATE is FDA application ANDA089828, sponsored by STRIDES PHARMA INTL. 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 II2018-04-24
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to

Class II2020-03-18
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class II2020-03-18
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class II2020-03-18
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Top Reported Reactions

1
DYSPNOEA
106 reports
2
COMPLETED SUICIDE
100 reports
3
DRUG INTERACTION
76 reports
4
NAUSEA
72 reports
5
VOMITING
69 reports
6
MALAISE
68 reports
7
DIZZINESS
67 reports
8
ABDOMINAL PAIN
62 reports
9
HEADACHE
57 reports
10
RASH
57 reports