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.
Product description
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
Lot numbers, UPCs & expiration codes
Lot #: 18103A, Exp 6/20
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0297-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 4, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 2976 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Epic Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0297-2019, exactly as published.
Show all FDA fields
- City
- Laurelton
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81729
- Address
- 22715 N Conduit Ave
- Code information
- Lot #: 18103A, Exp 6/20
- Postal code
- 11413-3134
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0297-2019
- Classification
- Class II
- Recalling firm
- Epic Pharma, LLC
- Product quantity
- 2976 bottles
- Termination date
- Feb 9, 2021
- Reason for recall
- Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Dec 4, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 14, 2018