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 II2021-10-26
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perri

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the e

Class II2020-02-03
Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 09

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement ta

Class I2021-03-02
Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI

Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count

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 II2025-12-16
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, ND

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

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 II2025-03-13
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count pack

CGMP Deviations

Class I2024-07-11
Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distrib

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the dru

Class II2021-10-26
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corpo

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the e

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

Top Reported Reactions

1
DRUG DEPENDENCE
34,597 reports
2
PAIN
31,758 reports
3
OVERDOSE
24,820 reports
4
OFF LABEL USE
24,436 reports
5
FATIGUE
23,897 reports
6
DRUG INEFFECTIVE
21,984 reports
7
NAUSEA
21,199 reports
8
HEADACHE
19,439 reports
9
TOXICITY TO VARIOUS AGENTS
17,546 reports
10
DYSPNOEA
16,684 reports