Glenmark Recalls Estradiol Vaginal Inserts Due to Applicator Defect
Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts because the applicator plunger may be difficult to push.
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 recall is classified as FDA Class II, and the hazard is a mechanical defect in the delivery system (applicator) rather than a chemical or biological contamination risk.
Plain-English summary
Glenmark Pharmaceuticals Inc. is recalling Estradiol Vaginal Inserts USP, 10 mcg, in 8-count and 18-count cartons. The recall is due to complaints that the plunger of the disposable applicator is difficult to push.
The affected products are prescription-only and were distributed nationwide in the USA. The recall involves specific batch numbers manufactured in 2018 and 2019, with distribution dates ranging from April to June 2020.
Consumers with these products should stop using them and contact their healthcare provider or the manufacturer for instructions on how to proceed.
The recalled product
- Product
- ESTRADIOL VAGINAL INSERTS (ESTRADIOL)
- Brand
- ESTRADIOL VAGINAL INSERTS
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 216,840
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 (12)
- Batch numbers: a) 20180514
- 20180544
- Apr-2020
- 20180545
- 20180546
- 20180588
- May-2020
- 20190003
- Jun-2020
- b) 20180515
- 20180543
- 20180587
UPCs (2)
- 0368462711880
- 0368462711712
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ESTRADIOL VAGINAL INSERTS
- ModerateGlenmark Recalls Estradiol Vaginal Inserts Due to Defective Plunger
FDA (Drugs) · 2019-06-19
- ModerateGlenmark Recalls Estradiol Vaginal Inserts Due to Malfunctioning Applicator Plunger
FDA (Drugs) · 2019-01-16
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