Drug product
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
D-1051-2014
Product summary
- Event
- Event 64922
- Status
- Terminated
- Classification
- Class I
- Quantity
- 285 vials
- Official record key
drug-enforcement:D-1051-2014
Official wording
Reason: 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.
Code information: Lot #s: N06252012@6 Exp 6/25/13; N01042013@15 Exp 1/29/14; N05072012@3 Exp 2/1/15
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility