CLINDAMYCIN PHOSPHATE
Generic: CLINDAMYCIN PHOSPHATE
E. Fougera & Co. a division of Fougera PharmaceuticalsManufacturer
TOPICALRoute
CLINDAMYCIN PHOSPHATEActive Substance
2002-01-31Original Approval
CLINDAMYCIN PHOSPHATE is FDA application ANDA065067, sponsored by FOUGERA PHARMS. 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 II2026-08-06
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, StCGMP Deviations
Class II2026-08-06
Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, StCGMP Deviations
Class II2026-08-06
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, SteriCGMP Deviations
Class II2016-12-28
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mo
Class III2025-11-26
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro PharmaceFailed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class II2026-08-06
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, SteriCGMP Deviations
Class II2026-08-06
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY ContainerCGMP Deviations
Top Reported Reactions
1
DRUG INEFFECTIVE
373 reports
2
RASH
251 reports
3
DRUG HYPERSENSITIVITY
228 reports
4
OFF LABEL USE
225 reports
5
DIARRHOEA
189 reports
6
NAUSEA
183 reports
7
FATIGUE
168 reports
8
PAIN
162 reports
9
PRURITUS
160 reports
10
CONDITION AGGRAVATED
136 reports