Why it was recalled
Lack of Assurance of Sterility
Product description
Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Lot numbers, UPCs & expiration codes
Lots: C253 BUD: 12/12/2018; D016 BUD: 1/18/2019
Where it was sold
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-0227-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 17, 2018
- FDA report date
- Nov 14, 2018
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualgen, LLC
Original FDA data
Every field from FDA enforcement report D-0227-2019, exactly as published.
Show all FDA fields
- City
- Edmond
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 81346
- Address
- 14844 Bristol Park Blvd
- Code information
- Lots: C253 BUD: 12/12/2018; D016 BUD: 1/18/2019
- Postal code
- 73013-1891
- Report date
- Nov 14, 2018
- Product type
- Drugs
- Recall number
- D-0227-2019
- Classification
- Class II
- Recalling firm
- Qualgen, LLC
- Termination date
- Jun 4, 2020
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
- Distribution pattern
- Nationwide.
- Recall initiation date
- Oct 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 7, 2018