Glenmark Recalls Estradiol Vaginal Inserts Due to Malfunctioning Applicator Plunger
Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts because customer complaints reported a malfunctioning plunger on the applicator delivery system.
What this means for you
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 FDA classified this as a Class II recall. The hazard is a mechanical defect in the delivery system (malfunctioning plunger) without reported injuries or illnesses, fitting the criteria for a moderate severity issue involving a functional defect rather than a direct toxicological or structural safety failure.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Estradiol Vaginal Inserts, USP, 10 mcg, due to a defective delivery system. The recall is based on customer complaints regarding a malfunctioning plunger on the applicator.
The affected product is a prescription-only medication packaged in 8-count and 18-count cartons. The specific batch numbers involved are 20180393, 20180424, 20180425, 20180427, 20180338, and 20180386. The product was distributed to five retailers and four distributors throughout the United States, who may have further distributed the recalled items.
Consumers should stop using the affected Estradiol Vaginal Inserts and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ESTRADIOL VAGINAL INSERTS (ESTRADIOL)
- Brand
- ESTRADIOL VAGINAL INSERTS
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Drug
- Affected units
- 96,240
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 (9)
- Batch numbers: a) 20180393
- exp. date 01/31/2020
- 20180424
- exp. date 02/29/2020
- 20180425
- 20180427
- b) 20180338
- exp. date 12/31/2019
- 20180386
UPCs (2)
- 0368462711880
- 0368462711712
Distribution
Distribution scope not specified by the agency.
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- ModerateGlenmark Recalls Estradiol Vaginal Inserts Due to Applicator Defect
FDA (Drugs) · 2019-11-06
- ModerateGlenmark Recalls Estradiol Vaginal Inserts Due to Defective Plunger
FDA (Drugs) · 2019-06-19
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