Drug product
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
D-0297-2019
Product summary
- Firm
- Epic Pharma, LLC
- Event
- Event 81729
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2976 bottles
- Official record key
drug-enforcement:D-0297-2019
Official wording
Reason: Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Code information: Lot #: 18103A, Exp 6/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign tablet