Why it was recalled
Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Product description
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
Lot numbers, UPCs & expiration codes
Lot #: 05272016@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-0436-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 18, 2016
- FDA report date
- Jan 25, 2017
- Quantity
- 101 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Town and Country Compounding and Consultation Services, LLC
Original FDA data
Every field from FDA enforcement report D-0436-2017, exactly as published.
Show all FDA fields
- City
- Ridgewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75700
- Address
- 106 Prospect St Ste 2
- Code information
- Lot #: 05272016@17
- Postal code
- 07450-4433
- Report date
- Jan 25, 2017
- Product type
- Drugs
- Recall number
- D-0436-2017
- Classification
- Class III
- Recalling firm
- Town and Country Compounding and Consultation Services, LLC
- Product quantity
- 101 vials
- Termination date
- Jan 14, 2021
- Reason for recall
- Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 18, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 19, 2017