Glenmark Recalls Estradiol Vaginal Inserts Due to Defective Plunger
Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts because the plunger delivery system is not functioning properly.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a mechanical failure of the delivery system rather than a direct toxicological hazard or reported injury.
Plain-English summary
Glenmark Pharmaceuticals Inc. is recalling Estradiol Vaginal Inserts USP 10 mcg, packaged in boxes of 8. The recall affects 31,656 boxes distributed nationwide in the United States. The specific lot number is 20180516, with an expiration date of 4/30/2020.
The recall was initiated because the plunger in the delivery system is not functioning properly. This defect may prevent the vaginal insert from being administered correctly.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on how to dispose of the product or obtain a replacement.
The recalled product
- Product
- ESTRADIOL VAGINAL INSERTS (ESTRADIOL)
- Brand
- ESTRADIOL VAGINAL INSERTS
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Drug
- Affected units
- 31,656
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 (2)
- Lot#: 20180516
- Exp 4/30/2020
UPCs (2)
- 0368462711880
- 0368462711712
Distribution
Distributed nationwide across the United States.
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