Drug product
Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01
D-0135-2020
Product summary
- Firm
- Epic Pharma, LLC
- Event
- Event 83849
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,472 (bottles of 100)
- Official record key
drug-enforcement:D-0135-2020
Official wording
Reason: Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Code information: Lot #: 19094A, Exp. 2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets