Hydrocortisone FDA Alerts
The FDA Alerts below may be specifically about hydrocortisone or relate to a group or class of drugs which include hydrocortisone.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for hydrocortisone
Piyanping Anti-Itch Lotion: Recall - Incorrect Active Ingredient
ISSUE: Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling.
Dexamethasone is a higher potency steroid than hydrocortisone and may have a longer half-life; it could potentially cause serious side effects in patients applying the cream multiple times daily. There is a reasonable probability of any or all of the following side effects of topical steroids which include but are not limited to skin changes (whitening, thinning), adrenal suppression (high blood sugar, weakened immunity, electrolyte imbalances, emotional lability, slowing of growth in children), glaucoma, and cataracts. To date Lucky Mart Inc. has not received any reports of adverse events related to this recall.
BACKGROUND: The product is an itch lotion and is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes in adults and children ages two and older. Products are packaged in a 0.67 oz (20g) tube in a paper carton. Lots C14005 (Exp. 03/2017), C16001 (Exp. 12/2018), C16002 (Exp. 12/2018). NDC 68085-8012-4. Piyanping Anti-Itch Lotion was distributed Nationwide in the USA to herbal and ethnic grocery stores. Lot # and Expiration Date can be found on the right side of the box, opposite of the barcode.
RECOMMENDATION: Consumers that may have product which is being recalled should stop use and return to place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product and are encouraged to report any adverse events to FDA’s MedWatch Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
[08/30/2017- Recall - Lucky Mart Inc.]
More hydrocortisone resources
- Vanicream HC Consumer Information
- Hydrocortisone rectal cream, suppository Consumer Information
- Hydrocortisone topical Consumer Information
- Anusol HC Advanced Consumer Information
- Corticool Maximum Strength Advanced Consumer Information
- Delacort Advanced Consumer Information
- Dermarest Advanced Consumer Information
- Hydrocortisone (Topical application) Advanced Consumer Information
- Hydrocortisone butyrate Advanced Consumer Information
- Hydrocortisone probutate Advanced Consumer Information
- Hydrocortisone valerate Advanced Consumer Information
- Hydrozone Plus Advanced Consumer Information
- Instacort-10 Advanced Consumer Information
- Ivy Soothe Advanced Consumer Information
- IvyStat Advanced Consumer Information
- Kericort 10 Advanced Consumer Information
- Medi-Cortisone Maximum Strength Advanced Consumer Information
- Microcort Advanced Consumer Information
- Mycin Scalp Advanced Consumer Information
- Neutrogena T/Scalp Advanced Consumer Information
- Nupercainal HC Advanced Consumer Information
- Pediaderm HC Kit Advanced Consumer Information
- Sarnol-HC Maximum Strength Advanced Consumer Information
- Summer's Eve Specialcare Advanced Consumer Information
- Therasoft Anti-Itch & Dermatitis Advanced Consumer Information
- Hydrocortisone (Topical) AHFS DI Monograph
- Hemorrhoidal-HC Consumer Information
- Hydrocortisone Cream, Gel, Ointment, and Solution Consumer Information
- Hydrocortisone Lotion Consumer Information
- Hydrocortisone Lotion and Protective Emollient Cream Consumer Information
- Hydrocortisone Rectal Cream Consumer Information
- Hydrocortisone Rectal Suppositories Consumer Information
- Hydrocortisone with Aloe Cream, Gel, and Ointment Consumer Information
- Anusol HC Prescribing Information
- Cortifoam Prescribing Information
- HOME PAPKIT Prescribing Information
- Hydrocort Lotion Prescribing Information
- Hydrocortisone Prescribing Information
- Hydrocortisone 2.5% Prescribing Information
- Hydrocortisone Butyrate Prescribing Information
- Hydrocortisone Butyrate Lotion Prescribing Information
- Hydrocortisone Butyrate Ointment Prescribing Information
- Hydrocortisone Butyrate Solution Prescribing Information
- Hydrocortisone Cream Prescribing Information
- Hydrocortisone Cream 2.5% Prescribing Information
- Hydrocortisone Lotion Prescribing Information
- Hydrocortisone Ointment Prescribing Information
- Hydrocortisone Suppository Prescribing Information
- Hydrocortisone Valerate Cream Prescribing Information
- Hydrocortisone Valerate Ointment Prescribing Information
- Hydrocortisone in Absorbase Prescribing Information
- Procto-kit Prescribing Information