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.
What this means for you
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
- processing-control-defect
- contamination-risk
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.
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