American Pharmaceutical Ingredients Recalls Tacrolimus USP Due to Stability Data Gaps
American Pharmaceutical Ingredients is recalling specific lots of Tacrolimus USP for prescription compounding because the manufacturer lacked stability data to support the assigned 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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a CGMP deviation regarding stability data rather than a confirmed contamination or acute injury risk, fitting the Moderate severity criteria for labeling or process errors without reported harm.
Plain-English summary
American Pharmaceutical Ingredients, LLC is recalling specific lots of Tacrolimus USP (Monohydrate) for prescription compounding. The affected products are packaged in 1g and 5g containers and are designated for prescription use only. The recall involves Lot 053116-1R, which has an expiration date of 04/30/2018.
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 deficiency means the product's stability over time has not been adequately verified.
The affected product was distributed nationwide within the USA. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 75
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 (3)
- Lot #: a) 053116-1R
- Exp.04/30/2018
- b) 053116-1R
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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