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.
Product description
Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01
Lot numbers, UPCs & expiration codes
Lot #: 19094A, Exp. 2021
Where it was sold
Nationwide within the United States
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-0135-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 26, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 11,472 (bottles of 100)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Epic Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0135-2020, exactly as published.
Show all FDA fields
- City
- Laurelton
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83849
- Address
- 22715 N Conduit Ave
- Code information
- Lot #: 19094A, Exp. 2021
- Postal code
- 11413-3134
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0135-2020
- Classification
- Class II
- Recalling firm
- Epic Pharma, LLC
- Product quantity
- 11,472 (bottles of 100)
- Termination date
- May 31, 2023
- Reason for recall
- Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 26, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2019