Lucky Mart Inc., is recalling three lots of Piyanping Anti-Itch Lotion because the products were manufactured with the active pharmaceutical ingredient dexamethasone rather than hydrocortisone, and dexamethasone is not listed on the lotions’ labels.
Dexamethasone is a higher potency steroid than hydrocortisone and may have a longer half-life, which has the potential to cause serious side effects in patients who use the lotion multiple times a day.
The recall is being initiated because there is a reasonable probability that any or all of the following side effects of topical steroids could occur – skin changes such as whitening or 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 adverse event reports related to this recall.
Piyanping Anti-Itch Lotion is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes in adults and children ages 2 and older. Affected lotions are packaged in a 0.67 oz (20g) tube in a paper carton. Affect lots are C14005 (Exp. 03/2017), C16001 (Exp. 12/2018), C16002 (Exp. 12/2018). NDC 68085-8012-4. The lotions were distributed nationwide to herbal and ethnic grocery stores.
Any consumers with these recalled lotions should stop using them immediately and return them to the place of purchase. Any adverse events experienced after using Piyanping Anti-Itch Lotion should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice