Class II
Terminated
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
- Recall Initiated
- December 26, 2018
- Posted
- January 16, 2019
- Recall Number
- D-0350-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 96,240 applicators
- Firm Location
- Mahwah, NJ, United States
Reason for Recall
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.
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
More recalls by Glenmark Pharmaceuticals Inc., Usa
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pi...
Dec 17, 2025 · Class III
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP...
Oct 22, 2025 · Class II
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceut...
Oct 1, 2025 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026