Drug recall D-0543-2024
Product
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
Reason for recall
Failed Impurities/Degradation Specifications.
Lots and codes
Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- 13,440 units
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 16, 2024
Related products
- Estradiol – drug information
- NDC 70710-1192 Estradiol · Estradiol .0375 mg/d · Zydus Pharmaceuticals USA Inc.
- NDC 70710-1195 Estradiol · Estradiol .1 mg/d · Zydus Pharmaceuticals USA Inc.
- NDC 70710-1193 Estradiol · Estradiol .05 mg/d · Zydus Pharmaceuticals USA Inc.
- NDC 70710-1194 Estradiol · Estradiol .075 mg/d · Zydus Pharmaceuticals USA Inc.
- NDC 70710-1191 Estradiol · Estradiol .025 mg/d · Zydus Pharmaceuticals USA Inc.