The Recall Desk
ModerateFDA (Drugs)·D-0881-2017·Announced 2017-06-14

Spectrum Laboratory Estradiol API Recalled for CGMP Deviations

Spectrum Laboratory Products is recalling Estradiol active pharmaceutical ingredient due to Good Manufacturing Practice deviations found during an FDA inspection.

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 involves a temporary or medically reversible adverse health consequence. The source cites CGMP deviations without reporting specific injuries or illnesses, fitting the Moderate severity criteria for manufacturing quality issues.

Plain-English summary

Spectrum Laboratory Products, Inc. is recalling Estradiol (17-B-Estradiol) Plant Base, Micronized, U.S.P. active pharmaceutical ingredient. The product is packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers and is marked for prescription use only. The recall involves 48 containers distributed nationwide in the USA.

The recall is being conducted due to deviations from current Good Manufacturing Practices (CGMP) identified during a recent FDA inspection of the active pharmaceutical ingredient manufacturer. This action follows a recall notice issued by the API manufacturer regarding these manufacturing deviations.

The affected lots are 2FH0257 (Expiration 09/30/2017) and 2GA0254 (Expiration 03/24/2018). Consumers and healthcare providers should stop using the product and contact the recalling firm or their healthcare provider for instructions on return or disposal.

The recalled product

Product
Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Pr
Manufacturer
Spectrum Laboratory Products, Inc.
Category
Drug — Active Pharmaceutical Ingredient
Hazard
Affected units
48

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 (4)

  • Lot #: 2FH0257
  • Exp 09/30/2017
  • 2GA0254
  • Exp 03/24/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Spectrum Laboratory Products, Inc. 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 2 products in this recall →

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