CLINDAMYCIN HYDROCHLORIDE

Generic: CLINDAMYCIN HYDROCHLORIDE

GLENMARK PHARMACEUTICALS INC.Manufacturer
ORALRoute
CLINDAMYCIN HYDROCHLORIDEActive Substance
2023-03-10Original Approval

CLINDAMYCIN HYDROCHLORIDE is FDA application ANDA216957, sponsored by GLENMARK PHARMS LTD. 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 II2025-03-13
Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pi

CGMP Deviations

Class II2021-03-15
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Bru

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
DIARRHOEA
269 reports
2
RASH
258 reports
3
OFF LABEL USE
256 reports
4
NAUSEA
237 reports
5
PAIN
214 reports
6
DYSPNOEA
199 reports
7
DRUG HYPERSENSITIVITY
189 reports
8
DRUG INEFFECTIVE
189 reports
9
HEADACHE
168 reports
10
PRURITUS
164 reports