Key Takeaway

HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244 by NuVision Pharmacy, Inc. was recalled on April 15, 2013. The hazard: Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control pr...

FDA Drug Class I Terminated

HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244

Recalled: April 15, 2013 ~285 vials units affected D-1051-2014

Description

HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244

Hazard / 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.

Class I: Dangerous or defective product that could cause serious health problems or death.

Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.

Products Affected

HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244

Drugs

Company Information

NuVision Pharmacy, Inc.

Dallas, TX, United States

View all 3 recalls by NuVision Pharmacy, Inc. →

Distribution

Nationwide

Related Recalls

FDA Drug Class I

Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244

April 15, 2013
FDA Drug Class II

Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244

March 28, 2013

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.