Kalchem Recalls Vardenafil HCl Due to Missing Stability Data
Kalchem International is recalling Vardenafil HCl 500 GM jars due to a lack of stability data supporting the expiration date.
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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a documentation and stability control issue (lack of data) rather than a confirmed contamination or defect causing immediate harm, fitting the Moderate category for low-risk or theoretical hazards.
Plain-English summary
Kalchem International, Inc. is recalling Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, NDC 60592-330-05. The product is an Rx-only bulk ingredient intended for manufacturing, repackaging, and processing for Rx and research purposes. The specific lot number is 070717-1.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the firm lacked the necessary stability data and controls to support the assigned retest or expiration date for the product in its container/closure system.
The affected product was distributed to Texas. Because this is a bulk pharmaceutical ingredient intended for manufacturing and research, it is not intended for direct consumer use. Recipients of this product should stop using it and contact the recalling firm for instructions.
The recalled product
- Product
- Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
- Manufacturer
- Kalchem International, Inc.
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 (1)
- Lot #: 070717-1
Distribution
Distributed in 1 state:
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