MasterPharm Recalls Vardenafil Troches Due to Lack of Processing Controls
MasterPharm LLC is recalling Vardenafil 20 mg Troches nationwide due to a lack of processing controls that ensures conformity to specifications.
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 a lack of processing controls. Per the rubric, this falls under 'voluntary precautionary recalls' or minor quality issues where no specific injury or illness is reported, aligning with a Moderate severity score.
Plain-English summary
MasterPharm LLC is voluntarily recalling Vardenafil 20 mg Troches, 30 troches per bottle, from the U.S. market. The recall is being conducted because of a lack of processing controls, which means there is a lack of assurance that the product conforms to specifications.
The affected product is distributed nationwide in the United States. The recall involves specific lots with the following codes and best-use-by dates: 01-21-2020:42@8 (BUD 7/19/2020), 01-24-2020:59@1 (BUD 7/22/2020), and 02-04-2020:65@11 (BUD 8/2/2020). The total quantity involved is 134 troches.
Consumers who have purchased this product should stop using it and contact MasterPharm LLC at (866) 630-5600 for further instructions or a refund. The FDA has classified 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
- Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
- Manufacturer
- MasterPharm LLC
- Category
- Drug — Prescription Medication
- Affected units
- 134
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)
- 01-21-2020:42@8
- BUD 7/19/2020 01-24-2020:59@1
- BUD 7/22/2020 02-04-2020:65@11
- BUD 8/2/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by MasterPharm LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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