CLOBETASOL PROPIONATE

Generic: CLOBETASOL PROPIONATE

Alembic Pharmaceuticals Inc.Manufacturer
TOPICALRoute
CLOBETASOL PROPIONATEActive Substance
2019-03-04Original Approval

CLOBETASOL PROPIONATE is FDA application ANDA211800, sponsored by ALEMBIC. 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 III2017-12-21
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Isra

Failed Content Uniformity Specifications

Class I2021-12-15
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay,

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

Class II2026-08-03
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34

Failed content uniformity specifications.

Class III2019-01-11
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plains

Defective Container; complaints of leakage.

Class III2023-01-20
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Mar

Subpotent Drug: Low assay result observed during long-term stability testing.

Class III2019-11-15
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manu

Defective delivery system; product is not foaming or is coming out as liquid.

Class III2017-06-02
G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31,

Failed impurities/degradation specifications: This product is being recalled due to out of specifica

Class III2019-11-15
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-62

Defective delivery system; product is not foaming or is coming out as liquid.

Top Reported Reactions

1
DRUG INEFFECTIVE
1,076 reports
2
PRURITUS
917 reports
3
OFF LABEL USE
686 reports
4
RASH
657 reports
5
PSORIASIS
539 reports
6
PRODUCT USE IN UNAPPROVED INDICATION
531 reports
7
FATIGUE
509 reports
8
HEADACHE
489 reports
9
DIARRHOEA
434 reports
10
NAUSEA
432 reports