The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1185-2022·Announced 2022-07-13

Estriol Vaginal Cream Recalled for Insanitary Manufacturing Conditions

Wedgewood Village Pharmacy is recalling Estriol 1mg/gm Vaginal Cream due to insanitary manufacturing conditions and lack of adequate processing controls identified during FDA inspection. The product was distributed nationwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a pharmaceutical product due to insanitary processing conditions and lack of adequate controls identified during FDA inspection. No illnesses, injuries, or confirmed contamination have been reported. Per the severity rubric, recalls without reported illness/injury where the hazard is theoretical are scored at most 3 (High).

Plain-English summary

Wedgewood Village Pharmacy, LLC is recalling Estriol 1mg/gm Vaginal Cream in 30 gm tubes due to insanitary manufacturing conditions. The affected lot is #000-03807142 with an expiration date of 08/27/22.

During a recent FDA inspection, the agency identified a lack of adequate processing controls at the manufacturer. The product was distributed nationwide in the United States.

Patients currently using this product should consult with their healthcare provider. The recalled product should not be used and should be returned to the pharmacy for return or disposal instructions.

The recalled product

Product
Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Manufacturer
Wedgewood Village Pharmacy, LLC
Category
Drug
Hazard
Affected units
1

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)

  • Lot#: 000-03807142 Exp Date: 08/27/22

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Wedgewood Village Pharmacy, 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 6 products in this recall →

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