Tadalafil USP Recall Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Tadalafil USP for prescription compounding due to a lack of stability data supporting expiration dates.
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 and involves a CGMP deviation regarding stability data without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Tadalafil USP (Monohydrate) for prescription compounding. The product is available in 5g, 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the USA.
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 recall affects pharmacies and compounding facilities that may have purchased or received these specific lots of Tadalafil USP. Consumers should contact their pharmacist or healthcare provider if they have questions regarding this recall.
The recalled product
- Product
- Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highlan
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 90,000
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 (20)
- Lot #: a) 020717-3
- Exp. 12/31/2021
- b) 020717-2 020717-4
- 020717-5 Exp. 12/31/2021
- 092816-2
- 092816-3
- Exp. 07/31/2021
- 121015-4
- 121015-5
- 121015-6
- Exp.10/31/2020
- c) 020717-1
- 020717-4
- 020717-5
- 092816-1
- 121015-1
- 121015-3
- Exp. 10/31/2020
- d) 020717-1
- 020717-2
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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