FDA Recalls Leucovorin Calcium Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Leucovorin Calcium USP for prescription compounding because it lacks stability data to support its 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a documentation and stability data deficiency rather than a confirmed contamination or acute safety failure, fitting the 'Moderate' criteria for low-risk or precautionary issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Leucovorin Calcium USP intended for prescription compounding. The product is manufactured by American Pharmaceutical Ingredients LLC and is available in 100mg, 1g, 5g, and 25g packages. The recall affects lots distributed nationwide within the United States.
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 current container/closure system. This means the product's shelf life and safety over time have not been adequately verified.
Healthcare providers and pharmacies should stop using the affected lots and return them to the manufacturer. Patients who have received this medication should consult their healthcare provider for guidance on whether to continue using the product or seek an alternative.
The recalled product
- Product
- Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), 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
- 240
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 (7)
- Lot #: a) 092415-1
- Exp. 05/21/2018
- b) 092415-1
- 122915-1
- Exp. 05/15/2018
- c) 092415-1
- Exp. 05/15/2018 d) 092415-1
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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