Estriol Vaginal Cream Recalled Due to Insanitary Manufacturing Conditions
Wedgewood Village Pharmacy is recalling Estriol vaginal cream nationwide due to insanitary manufacturing conditions and lack of processing controls identified during an FDA inspection.
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 FDA Class II recall involves a compounded pharmaceutical product with observed manufacturing deficiencies (insanitary conditions and lack of processing controls). No illnesses or injuries have been reported in the source material, so per the rubric, the score cannot exceed 3 for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Wedgewood Village Pharmacy, LLC is recalling Estriol 1mg/gm Vaginal Cream (60 gram tube) due to manufacturing deficiencies. The recalled lot is #000-03866709 with an expiration date of 09/18/22.
During a recent FDA inspection, insanitary conditions and lack of processing controls were observed at the manufacturing facility. These manufacturing deficiencies may affect the safety and quality of the product.
The product was distributed nationwide in the United States.
Consumers who have received this product should stop using it and contact their healthcare provider or pharmacy for guidance. Questions about this recall may be directed to Wedgewood Village Pharmacy, LLC at 405 Heron Drive, Suite 200, Swedesboro, NJ 08085.
The recalled product
- Product
- Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
- Manufacturer
- Wedgewood Village Pharmacy, LLC
- Category
- Drug — Compounded Pharmaceutical
- Hazard
- insanitary-conditions
- manufacturing-defect
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#: 000-03866709 Exp Date: 09/18/22
Distribution
Distributed nationwide across the United States.
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