The Recall Desk
ModerateFDA (Drugs)·D-0560-2021·Announced 2021-06-02

Cardinal Health Recalls Intrarosa Prasterone Vaginal Inserts Due to Temperature Excursions

Cardinal Health Inc. is recalling 205 cartons of Intrarosa Prasterone Vaginal Inserts due to intermittent temperature excursions during storage.

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 reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves storage conditions rather than a direct contamination or structural defect, and no illnesses or injuries are reported in the source text.

Plain-English summary

Cardinal Health Inc. is recalling 205 cartons of Intrarosa Prasterone Vaginal Inserts, 6.5 mg, 28 inserts/applicators. The product is distributed by AMAG Pharmaceuticals, Inc. and manufactured for Ednoceutics, Inc.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The specific lot code for the recalled product is R81339.

The recalled product

Product
Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451, NDC 64011-601-28
Manufacturer
Cardinal Health Inc.
Category
Drug — Vaginal Insert
Hazard
Affected units
205

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 (1)

  • R81339

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health 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 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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