Recalls / Class II
Class IID-0350-2019
Product
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ
- Brand name
- Estradiol Vaginal Inserts
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Vaginal
- NDC
- 68462-711
- FDA application
- ANDA210264
- Affected lot / code info
- Batch numbers: a) 20180393, exp. date 01/31/2020, 20180424, exp. date 02/29/2020, 20180425, exp. date 02/29/2020, 20180427, exp. date 02/29/2020; b) 20180338, exp. date 12/31/2019, 20180386, exp. date 01/31/2020
Why it was recalled
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 96,240 applicators
- Distribution pattern
- Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
Timeline
- Recall initiated
- 2018-12-26
- FDA classified
- 2019-01-08
- Posted by FDA
- 2019-01-16
- Terminated
- 2020-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0350-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.