Ascend Recalls EstroGel Pump Defect
Ascend Therapeutics is recalling 4,835 bottles of EstroGel (estradiol gel) 0.06% because the pump head may detach from the canister.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is a mechanical packaging defect.
Plain-English summary
Ascend Therapeutics Inc is voluntarily recalling 4,835 bottles of EstroGel (estradiol gel) 0.06% in 50-gr metered pumps. The product is labeled for use as physician starter samples and was distributed nationwide. The specific lot number is EHAD with an expiration date of 07/14.
The recall was initiated due to a defective container where the pump head may detach from the canister unit upon removal of the overcap. This defect is a packaging and mechanical issue rather than a chemical or biological contamination of the medication itself.
Consumers and healthcare providers with this product should stop using it and contact Ascend Therapeutics for instructions on return or disposal. The agency has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***
- Manufacturer
- Ascend Therapeutics Inc
- Category
- Drug — Hormone Therapy
- Hazard
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 Number: EHAD Exp. 07/14
Distribution
Distributed nationwide across the United States.
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