PENICILLAMINE

Generic: PENICILLAMINE

Granules Pharmaceuticals Inc.Manufacturer
ORALRoute
PENICILLAMINEActive Substance
2020-12-02Original Approval

PENICILLAMINE is FDA application ANDA211735, sponsored by GRANULES. 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 II2023-11-22
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD

Failed Dissolution Specifications

Top Reported Reactions

1
DRUG HYPERSENSITIVITY
176 reports
2
DRUG INEFFECTIVE
166 reports
3
ARTHRALGIA
148 reports
4
JOINT SWELLING
141 reports
5
INFLAMMATION
111 reports
6
DIARRHOEA
87 reports
7
NAUSEA
85 reports
8
HYPERSENSITIVITY
79 reports
9
DRUG INTOLERANCE
78 reports
10
ANAPHYLACTIC REACTION
77 reports