Drug recall D-0527-2021
Product
Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
3108206
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 72 cartons
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Estradiol – drug information
- NDC 0378-4620 Estradiol · Estradiol .0375 mg/d · Mylan Pharmaceuticals Inc.
- NDC 0378-4619 Estradiol · Estradiol .025 mg/d · Mylan Pharmaceuticals Inc.
- NDC 0378-4623 Estradiol · Estradiol .1 mg/d · Mylan Pharmaceuticals Inc.
- NDC 0378-4621 Estradiol · Estradiol .05 mg/d · Mylan Pharmaceuticals Inc.
- NDC 0378-4622 Estradiol · Estradiol .075 mg/d · Mylan Pharmaceuticals Inc.