Ephedrine Plus tablets recalled for cGMP manufacturing deviations
Ultra Seal Corporation is recalling Ephedrine Plus tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 301,842 bottles distributed across the United States.
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: This is an FDA Class II recall involving cGMP manufacturing deviations without reported illness or injury. No hospitalization or harm has been reported, and the recall was voluntarily initiated by the firm as a precautionary measure.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets in 24-count bottles due to current Good Manufacturing Practice (cGMP) deviations.
The affected product includes Lot #18M063 (expiration date 01/2022) and Lot #19G076 (expiration date 09/2022). Approximately 301,842 bottles were distributed nationwide within the United States. The product is marketed by DMD Pharmaceuticals, a division of Dickery Consumer Products, Inc., located in Noblesville, Indiana.
The FDA classified this as a Class II recall. The firm initiated the recall on January 24, 2022, and the FDA classified it on January 31, 2022. The recall was terminated on October 16, 2023. Consumers who have this product should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Oral Tablet
- Hazard
- cgmp-deviation
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 (4)
- Lot#: 18M063
- Exp. Date 01/2022
- 19G076
- Exp. Date 09/2022
Distribution
Distributed nationwide across the United States.
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