HYDROCORTISONE

Generic: HYDROCORTISONE

Crown LaboratoriesManufacturer
TOPICALRoute
HYDROCORTISONEActive Substance
1973-03-09Original Approval

HYDROCORTISONE is FDA application ANDA080706, sponsored by CROWN LABS. 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 II2018-05-07
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrig

Failed Stability Specifications

Class II2021-03-15
HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class III2023-11-06
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related

Class II2018-12-07
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified

Class II2019-07-11
Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgree

CGMP Deviations: Out of Specification results for either total microbial count or total organic carb

Class II2019-07-11
Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carb

Class II2022-04-13
Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30

cGMP deviations: Temperature abuse

Class II2019-07-11
Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed By: Walgree

CGMP Deviations: Out of Specification results for either total microbial count or total organic carb

Class II2019-07-11
Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carb

Top Reported Reactions

1
OFF LABEL USE
11,018 reports
2
DRUG INEFFECTIVE
9,541 reports
3
FATIGUE
7,776 reports
4
CONDITION AGGRAVATED
6,885 reports
5
RASH
6,667 reports
6
PAIN
6,269 reports
7
NAUSEA
6,017 reports
8
ARTHRALGIA
5,543 reports
9
DIARRHOEA
5,517 reports
10
HEADACHE
5,460 reports