Why it was recalled
CGMP deviations- Lack of Quality Assurance
Product description
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
Lot numbers, UPCs & expiration codes
Lot# C018; Exp. 08/2/17 Lot# B151; Exp. 12/7/17 Lot# B108; Exp. 10/3/17 Lot# B095; Exp. 09/12/17 Lot# B062; Exp. 07/6/17 Lot# B035; Exp. 05/2/17 Lot# B133; Exp. 11/4/17
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-0892-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 19, 2017
- FDA report date
- Jun 14, 2017
- Quantity
- 6,361 pellets.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualgen
Original FDA data
Every field from FDA enforcement report D-0892-2017, 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# C018; Exp. 08/2/17 Lot# B151; Exp. 12/7/17 Lot# B108; Exp. 10/3/17 Lot# B095; Exp. 09/12/17 Lot# B062; Exp. 07/6/17 Lot# B035; Exp. 05/2/17 Lot# B133; Exp. 11/4/17
- Postal code
- 73013-1891
- Report date
- Jun 14, 2017
- Product type
- Drugs
- Recall number
- D-0892-2017
- Classification
- Class II
- Recalling firm
- Qualgen
- Product quantity
- 6,361 pellets.
- Termination date
- Sep 24, 2021
- Reason for recall
- CGMP deviations- Lack of Quality Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 19, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 7, 2017