CLASS I Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report
HCG (Lyophilized) Stock # 21714, 5000 IUnits- vial recalled
NuVision Pharmacy is recalling HCG (Lyophilized) Stock # 21714, 5000 IUnits- vial, Compounded by NuVision Pharmacy, distributed nationwide in the US. The recall was initiated on 15 Apr 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1051-2014
- FDA event ID
- 64922
- Recalling firm
- NuVision Pharmacy, Dallas, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Apr 2013
- FDA classified
- 30 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Apr 2013 | Recall initiated by company | |
| 30 Jan 2014 | Classified by FDA | +290 days |
| 5 Feb 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
Where it was distributed
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #s: N06252012@6 Exp 6/25/13; N01042013@15 Exp 1/29/14; N05072012@3 Exp 2/1/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 64922| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Sermorelin/Ghrp-6, 3 mg/3 mg vial, Stock # recalled by NuVision Pharmacy | NuVision Pharmacy | Sterility | Nationwide |
More recalls from NuVision Pharmacy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Sermorelin/Ghrp-6, 3 mg/3 mg vial, Stock # recalled by NuVision Pharmacy | NuVision Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin (Buffered) Injection,1 mg/mL vial recalled | NuVision Pharmacy | Sterility | 4 states |