Class II · Moderate risk
Sermorelin Lyophilized powder for reconstitution
Lack of Assurance of Sterility
Sermorelin/GHRP-6
Class I — High risk. Reasonable probability of serious harm or death.
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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244
Drug: Sermorelin
- Recalling firm
- NuVision Pharmacy, Inc.
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1052-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Sermorelin recalls
See all
Class II · Moderate risk
Sermorelin Acetate 1 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial
Lack of assurance of sterility.
Class II · Moderate risk
Sermorelin Acetate 1 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Ipamorelin Acetate/Sermorelin Acetate
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Other recalls by NuVision Pharmacy, Inc.
All 2013 recalls
Class I · High risk
HCG (Lyophilized)
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 II · Moderate risk
Methylcobalamin
Lack of Assurance of Sterility; reports of adverse events after injection
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