Recall: D-0350-2019

Class II - Potentially Harmful

Class IIClassification

2018-12-26Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

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

Reason

Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

Distribution

Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.