MINOCYCLINE HYDROCHLORIDE
Generic: MINOCYCLINE HYDROCHLORIDE
Zydus Lifesciences LimitedManufacturer
ORALRoute
MINOCYCLINE HYDROCHLORIDEActive Substance
1992-03-02Original Approval
MINOCYCLINE HYDROCHLORIDE is FDA application ANDA063009, sponsored by ZYDUS. 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 II2026-06-01
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem LaboraFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th
Class III2020-01-22
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem LaborFailed Dissolution Specifications: low out of specification results for dissolution testing.
Top Reported Reactions
1
DRUG INEFFECTIVE
1,225 reports
2
OFF LABEL USE
1,120 reports
3
DRUG INTOLERANCE
939 reports
4
RHEUMATOID ARTHRITIS
874 reports
5
PAIN
854 reports
6
NAUSEA
739 reports
7
ARTHRALGIA
731 reports
8
RASH
731 reports
9
DRUG HYPERSENSITIVITY
715 reports
10
JOINT SWELLING
709 reports