FDA Recalls AstrinGyn Surgical Hemostatic Due to Manufacturing Practice Deviations
Ecometics is recalling 92,967 vials of AstrinGyn (Ferric Subsulfate) Aqueous due to manufacturing practice violations. The product was not manufactured under current good manufacturing practices (CGMP).
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 a risk-of-harm product (surgical hemostatic agent) with identified manufacturing practice deviations. Although no injuries have been reported, CGMP violations represent a significant quality control concern for a medical drug product.
Plain-English summary
Ecometics, Inc. is recalling AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm single-use vials (NDC 59365-6065-0) manufactured for CooperSurgical. Approximately 92,967 vials are affected by this recall.
The recall was initiated because the recalled products were not manufactured under current good manufacturing practices (CGMP). CGMP are FDA requirements that establish minimum standards for manufacturing conditions and quality control of pharmaceutical products.
The affected product was distributed nationwide in the USA. The recall involves four lot numbers: 2E144A and 2E157A (expiration 11/2023), 2E270A (expiration 3/2024), and 2E300A (expiration 4/2024).
Healthcare providers and facilities that have received this product should stop using affected lot numbers immediately and contact the manufacturer or FDA for guidance on proper handling. Patients who received this product should contact their healthcare provider.
The recalled product
- Product
- AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
- Manufacturer
- Ecometics, Inc.
- Category
- Drug — Surgical Hemostatic
- Hazard
- cgmp-deviation
- 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 (7)
- Lot #: 2E144A
- 2E157A
- exp: 11/2023
- 2E270A
- exp: 3/2024
- 2E300A
- exp: 4/2024
Distribution
Distributed nationwide across the United States.
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