Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0522-2018·Announced 2018-02-28

Sumatriptan USP for Prescription Compounding Recalled Due to Stability Data Deficiencies

American Pharmaceutical Ingredients LLC is recalling Sumatriptan USP for prescription compounding due to a lack of stability data and controls to support assigned 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 involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific hazard is a documentation and stability data deficiency rather than a confirmed contamination or immediate physical danger, fitting the Moderate category for minor labeling or documentation errors.

Plain-English summary

American Pharmaceutical Ingredients LLC is recalling Sumatriptan USP for prescription compounding, packaged in 10g, 25g, and 100g containers. The product is prescription-only and was 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 container/closure system.

Healthcare professionals and patients should discontinue use of the affected lots and contact their pharmacist or the recalling firm for further instructions. The affected lot numbers are SUT1213030SP-11192014 (for 10g and 25g packages) and SUT1213030SP-7222015 (for 100g packages), all with an expiration date of 11/30/2018.

The recalled product

Product: Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Manufacturer: American Pharmaceutical Ingredients LLC
Category: Drug — Pharmaceutical Ingredient
Hazard: documentation-deficiency
stability-data-lack
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) SUT1213030SP-11192014
Exp. 11/30/2018
b) SUT1213030SP-11192014
exp. 11/30/2018
c) SUT1213030SP-7222015
Exp.11/30/2018.

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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