Ephedrine 25 Guaifenesin 200 Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Ephedrine 25 Guaifenesin 200 bulk tablets due to manufacturing practice deviations. The voluntary recall affects about 7.3 million tablets distributed to three drug wholesalers.
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 FDA classified this as a Class II recall for CGMP deviations. No reported illnesses, injuries, or deaths are stated in the source. The recall is voluntary and based on manufacturing practice violations without evidence of actual product harm.
Plain-English summary
ULTRAtab Laboratories, Inc., of Highland, New York, is voluntarily recalling Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) bulk containers bearing product code M320L and bulk lots 18M063 and 19G076. The recall affects approximately 7,297,709 tablets distributed to three wholesalers, who may have distributed finished product downstream.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. The FDA classified this as a Class II recall. The company notified the FDA by letter on January 26, 2022, and the FDA's Center for Drug Evaluation and Research made its classification on February 9, 2022.
Consumers or healthcare providers who have this product should stop use and contact their healthcare provider or the manufacturer for further guidance. The recall was terminated on January 7, 2025.
The recalled product
- Product
- Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- 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 (2)
- Product Codes: M320L Bulk Lots: 18M063
- 19G076
Distribution
Distribution scope not specified by the agency.
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