CIPROFLOXACIN

Generic: CIPROFLOXACIN

Hikma Pharmaceuticals USA Inc.Manufacturer
ORALRoute
CIPROFLOXACIN HYDROCHLORIDEActive Substance
2004-06-09Original Approval

CIPROFLOXACIN is FDA application ANDA076558, sponsored by HIKMA. 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 II2013-02-06
Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntow

Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ci

Class II2024-12-16
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged

Class II2025-08-13
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manuf

Temperature Abuse

Class II2025-03-11
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LL

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged

Class II2019-07-02
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 1193

Lack of Assurance of Sterility

Class II2019-07-02
Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05

Lack of Assurance of Sterility

Class II2019-07-02
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire Pharmaceuticals, Inc Aquebogue, NY 11931 N

Lack of Assurance of Sterility

Class II2024-07-23
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 693

Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged

Class II2022-04-13
Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05

cGMP deviations: Temperature abuse

Class III2012-03-09
Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Lab

Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is be

Top Reported Reactions

1
FATIGUE
4,790 reports
2
PAIN
4,651 reports
3
NAUSEA
4,610 reports
4
DIARRHOEA
4,590 reports
5
ACUTE KIDNEY INJURY
4,360 reports
6
DRUG INEFFECTIVE
4,345 reports
7
ARTHRALGIA
4,332 reports
8
CHRONIC KIDNEY DISEASE
4,106 reports
9
DRUG HYPERSENSITIVITY
3,924 reports
10
OFF LABEL USE
3,889 reports