Why it was recalled
Lack of assurance of sterility.
Product description
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lot numbers, UPCs & expiration codes
Lots: HCG1116 Exp. 3/31/2019; HCG1117 Exp. 4/30/2019
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-1148-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 2, 2018
- FDA report date
- Sep 5, 2018
- Quantity
- 864 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmcore Inc.
Original FDA data
Every field from FDA enforcement report D-1148-2018, exactly as published.
Show all FDA fields
- City
- Hallandale Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 80699
- Address
- 1109 E Hallandale Beach Blvd
- Code information
- Lots: HCG1116 Exp. 3/31/2019; HCG1117 Exp. 4/30/2019
- Postal code
- 33009-4431
- Report date
- Sep 5, 2018
- Product type
- Drugs
- Recall number
- D-1148-2018
- Classification
- Class II
- Recalling firm
- Pharmcore Inc.
- Product quantity
- 864 vials
- Termination date
- Jan 18, 2022
- Reason for recall
- Lack of assurance of sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2018