Procto-Pak 1% FDA Alerts
The FDA Alert(s) below may be specifically about Procto-Pak 1% or relate to a group or class of drugs which include Procto-Pak 1% (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. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for hydrocortisone
Piyanping Anti-Itch Lotion: Recall - Incorrect Active Ingredient
Aug 30, 2017
Audience: Consumer, Pharmacy
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.]