The Recall Desk
ModerateFDA (Drugs)·D-0500-2018·Announced 2018-02-28

Ketoprofen USP Micronized Recalled for Lack of Stability Data

American Pharmaceutical Ingredients LLC is recalling Ketoprofen USP (Micronized) 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a CGMP deviation regarding stability data rather than a confirmed contamination or acute injury risk.

Plain-English summary

American Pharmaceutical Ingredients LLC is recalling Ketoprofen USP (Micronized) for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is intended for prescription use only. The recall covers a total of 225,300 grams of the product.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the stability data and controls necessary to support the assigned retest or expiration dates for the product in its container/closure system.

The product was distributed nationwide within the United States. Affected lots include various expiration dates ranging from March 2018 to February 2022. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 4832
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
225,300

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 (15)

  • Lot #: a) 051916-1
  • Exp. 04/30/2019
  • 061015-1
  • Exp. 03/03/2018
  • 041216-2
  • Exp. 03/27/2019
  • b) 051916-1
  • 052517-1
  • Exp. 02/28/2022
  • c) 041216-1
  • 051916-3
  • d) 041216-1
  • 041216-3
  • 051916-2
  • 051916-4

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 →

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