FDA Recalls Zhong Hua Jiu Menthol Patches for GMP Deviations
United Pacific Co Ltd is recalling Zhong Hua Jiu (menthol 1%) Patches because they were produced with substandard GMP manufacturing processes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations. Per the rubric, this falls under 'voluntary precautionary recalls' or minor process errors without reported serious injury, warranting a Moderate severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Zhong Hua Jiu (menthol 1%) Patches distributed by United Pacific Company. The recall involves 15,190 boxes of the product, which were distributed nationwide within the United States. The specific product is identified by UPC 6 924938 100226 and NDC 53614-001-02.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. According to the source text, the product was produced with substandard GMP manufacturing processes. The affected lots include Lot #14122921 (Exp. 12/30/2019), Lot #15091512 (Exp. 9/15/2020), Lot #6032321 (Exp. 3/23/2021), and Lot #17030921 (Exp. 3/09/2022).
Consumers who have purchased these patches should stop using them and contact United Pacific Co Ltd for further instructions or a refund. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
- Manufacturer
- United Pacific Co Ltd
- Category
- Drug — Topical Analgesic
- Hazard
- Affected units
- 15,190
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #:14122921
- Exp.12/30/20119
- 15091512
- Exp. 9/15/2020
- 6032321
- Exp. 3/23/2021
- 17030921
- Exp. 3/09/2022
Distribution
Distributed nationwide across the United States.
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