Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0477-2018·Announced 2018-02-28

FDA Recalls Calcipotriene BP Due to Missing Stability Data

American Pharmaceutical Ingredients is recalling Calcipotriene BP for prescription compounding because it lacks stability data to support its expiration dates.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a documentation and stability data deficiency rather than a confirmed contamination or acute injury event.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Calcipotriene BP (Monohydrate) for prescription compounding. The product is available in 250mg, 500mg, and 1g packages and is packed by American Pharmaceutical Ingredients LLC in Waterford, Michigan. The recall covers specific lots with expiration dates of 04/30/2019.

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 stability have not been adequately verified.

The product was distributed nationwide within the United States. Because this is a prescription-only ingredient used for compounding, it is not typically sold directly to consumers. Pharmacies and compounding facilities that possess these specific lots should stop using them and follow the recall instructions provided by the firm.

The recalled product

Product: Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
Manufacturer: American Pharmaceutical Ingredients LLC
Category: Drug — Pharmaceutical Ingredient
Hazard: stability-data-deficiency
expiration-date-unsupported
Affected units: 10

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 (5)

Lot #: a) 050715-2
Exp. 04/30/2019
b) 050715-2
c) 050715-1
Exp. 04/30/2019.

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.

See all 66 products in this recall →

Same manufacturer · American Pharmaceutical Ingredients LLC

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