Recalls / Class II
Class IID-0135-2020
Product
Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01
- 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 #: 19094A, Exp. 2021
Why it was recalled
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Recalling firm
- Firm
- Epic Pharma, LLC
- Manufacturer
- EPIC PHARMA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 22715 N Conduit Ave, N/A, Laurelton, New York 11413-3134
Distribution
- Quantity
- 11,472 (bottles of 100)
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-09-26
- FDA classified
- 2019-10-09
- Posted by FDA
- 2019-10-16
- Terminated
- 2023-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0135-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.