FDA Warns Chinese Firm for Confusing API in OTC Drug
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last Monday to China-based Guangdong Zhanjiang Jimin Pharmaceutical Co. after finding that one of the over-the-counter drugs the firm made was labeled as containing the active pharmaceutical ingredient (API) hydrocortisone, but really the drug contained dexamethasone acetate.
The company told FDA that the mix-up is the result of "a translation mistake," according to the warning letter, though FDA notes that the firm’s quality unit approved multiple lots of the drug to be distributed in the US with this incorrect active ingredient.
And although all lots of the OTC drug shipped to the US were recalled on 30 August, FDA says the company has failed to provide additional details into its quality unit’s failure and action plan to prevent recurrence.
In addition, FDA, during a five-day inspection last May, found the company failed to test its drug products for identity and strength of active ingredients prior to release and distribution.
The letter adds that the firm’s OTC "Piyanping Anti-Itch Lotion," intended for external analgesic indications such as the relief of itching and which have been proposed to be classified as generally recognized as safe and effective and not misbranded under a Tentative Final Monograph (TFM), "is not formulated in conformance with the TFM. According to its label, Piyanping Anti-Itch Lotion contains hydrocortisone 1% as its active ingredient, when in fact, the active ingredient is dexamethasone acetate."
FDA also said the company’s "Shennong Analgesic Plaster," which includes the active ingredient methyl salicylate at a dosage range of 1.4%, "falls below what has been proposed in the External Analgesic TFM. The TFM proposes methyl salicylate in a dosage range of 10–60%."