Recalls / Class II
Class IID-0297-2019
Product
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
- Brand name
- Estradiol
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Oral
- NDCs
- 42806-087, 42806-088, 42806-089
- FDA application
- ANDA040275
- Affected lot / code info
- Lot #: 18103A, Exp 6/20
Why it was recalled
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Recalling firm
- Firm
- Epic Pharma, LLC
- Manufacturer
- EPIC PHARMA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 22715 N Conduit Ave, Laurelton, New York 11413-3134
Distribution
- Quantity
- 2976 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2018-12-04
- FDA classified
- 2018-12-14
- Posted by FDA
- 2018-12-26
- Terminated
- 2021-02-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0297-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.