Why it was recalled
CGMP deviations- Lack of Quality Assurance
Product description
Estradiol 10 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: 69761-010-01
Lot numbers, UPCs & expiration codes
Lot# C021; Exp. 08/20/17 Lot# B160, Exp. 12/29/17 Lot# B140; Exp. 11/15/17 Lot# B107; Exp. 09/29/17 Lot# B079; Exp. 08/15/17 Lot# B046; Exp. 06/01/17
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-0895-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 19, 2017
- FDA report date
- Jun 14, 2017
- Quantity
- 5,260 pellets.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualgen
Original FDA data
Every field from FDA enforcement report D-0895-2017, 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# C021; Exp. 08/20/17 Lot# B160, Exp. 12/29/17 Lot# B140; Exp. 11/15/17 Lot# B107; Exp. 09/29/17 Lot# B079; Exp. 08/15/17 Lot# B046; Exp. 06/01/17
- Postal code
- 73013-1891
- Report date
- Jun 14, 2017
- Product type
- Drugs
- Recall number
- D-0895-2017
- Classification
- Class II
- Recalling firm
- Qualgen
- Product quantity
- 5,260 pellets.
- Termination date
- Sep 24, 2021
- Reason for recall
- CGMP deviations- Lack of Quality Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol 10 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: 69761-010-01
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 19, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 7, 2017