Why it was recalled
CGMP deviations- Lack of Quality Assurance
Product description
Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
Lot numbers, UPCs & expiration codes
Lot # B128; Exp. 11/1/17 Lot # B075; Exp. 08/3/17
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-0890-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 19, 2017
- FDA report date
- Jun 14, 2017
- Quantity
- 1,666 pellets.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualgen
Original FDA data
Every field from FDA enforcement report D-0890-2017, exactly as published.
Show all FDA fields
- City
- Edmond
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 77064
- Address
- 14844 Bristol Park Blvd
- Code information
- Lot # B128; Exp. 11/1/17 Lot # B075; Exp. 08/3/17
- Postal code
- 73013-1891
- Report date
- Jun 14, 2017
- Product type
- Drugs
- Recall number
- D-0890-2017
- Classification
- Class II
- Recalling firm
- Qualgen
- Product quantity
- 1,666 pellets.
- Termination date
- Sep 24, 2021
- Reason for recall
- CGMP deviations- Lack of Quality Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 19, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 7, 2017