Why it was recalled
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Product description
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
Lot numbers, UPCs & expiration codes
Lot #s: N06252012@6 Exp 6/25/13; N01042013@15 Exp 1/29/14; N05072012@3 Exp 2/1/15
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-1051-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 15, 2013
- FDA report date
- Feb 5, 2014
- Quantity
- 285 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NuVision Pharmacy, Inc.
Original FDA data
Every field from FDA enforcement report D-1051-2014, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 64922
- Address
- 4001 McEwen Rd Suite 110
- Code information
- Lot #s: N06252012@6 Exp 6/25/13; N01042013@15 Exp 1/29/14; N05072012@3 Exp 2/1/15
- Postal code
- 75244-5020
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1051-2014
- Classification
- Class I
- Recalling firm
- NuVision Pharmacy, Inc.
- Product quantity
- 285 vials
- Termination date
- Feb 8, 2017
- Reason for recall
- Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 15, 2013
- Initial firm notification
- Press Release
- Center classification date
- Jan 30, 2014