The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0488-2018·Announced 2018-02-28

FDA Recalls Estradiol USP for Compounding Due to Stability Data Deficiencies

American Pharmaceutical Ingredients LLC is recalling Estradiol USP (Micronized) (Yam) 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as it represents a situation where use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol USP (Micronized) (Yam) intended for prescription compounding. The product is manufactured by American Pharmaceutical Ingredients LLC and is available in 1g, 5g, 10g, 25g, and 100g packages. The recall is classified as FDA Class II.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the retest or expiration dates assigned to the product in its container/closure system. This deficiency raises concerns about the product's quality and safety over time.

The affected product was distributed nationwide within the United States. Specific lot numbers and expiration dates are listed in the recall documentation. Healthcare providers and pharmacies should stop using the affected lots and contact the manufacturer for further instructions. Consumers who have purchased this product should consult their healthcare provider regarding its use.

The recalled product

Product
Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650…
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
2,000

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 (8)

  • Lot #: a) 111516-1
  • Exp. 09/19/2018
  • b) 011917A-1
  • Exp. 09/22/2018
  • c) 111516-1
  • d) 011917A-1
  • 111516-1
  • e) 011917A-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.

See all 66 products in this recall →

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