D-0297-2019 Class II Terminated
FDA drug recall D-0297-2019 was initiated by Epic Pharma, LLC on December 4, 2018 and is designated Class II. Reason for recall: Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets. The recall status is terminated (terminated February 9, 2021). Affected quantity: 2976 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 26, 2018
- Initiation Date
- December 4, 2018
- Termination Date
- February 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2976 bottles
Product Description
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
Reason for Recall
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 18103A, Exp 6/20