HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
FDA recall notice · announced February 5, 2014 · Nuvision Pharmacy
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The product
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
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.
Notes
Distribution: Nationwide
Lot/code information: Lot #s: N06252012@6 Exp 6/25/13; N01042013@15 Exp 1/29/14; N05072012@3 Exp 2/1/15
Quantity: 285 vials
Status: Terminated
Products in this recall event:
- Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244 (D-1052-2014)
- HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244 (D-1051-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.