FDA Recalls Vardenafil HCl for Prescription Compounding Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Vardenafil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe (Score 4), as they are not Class I (Critical) but involve significant regulatory deviations regarding product stability and expiration.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Vardenafil HCl USP (trihydrate) for prescription compounding, manufactured by American Pharmaceutical Ingredients LLC. The product is available in 5g, 100g, 500g, and 1000g packages and is distributed nationwide within the United States. The specific lots affected are 070717-2, 070717-1, and 070717-1, all with an expiration date of 05/31/2020.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its container/closure system. This classification is designated as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare professionals and pharmacies should discontinue use of the affected lots and return them to the manufacturer. Consumers who have purchased this prescription-only ingredient should contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 10,000
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 (6)
- Lot #: a) 070717-2
- Exp. 05/31/2020
- b) 070717-1
- c) 070717-1
- d) 070717-1
- Exp. 05/31/2020.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 66 recalled by American Pharmaceutical Ingredients 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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