CLASS II Drug recall · Reported 9 Oct 2019 · FDA Enforcement Report

Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized recalled

KRS Global Biotechnology is recalling Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, distributed nationwide in the US. The recall was initiated on 12 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots remaining within expiry.
Quantity recalled341 vials

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-0099-2020
FDA event ID
83789
Recalling firm
KRS Global Biotechnology, Boca Raton, FL
Classification
Class II
Status
Terminated
Recall initiated
12 Sep 2019
FDA classified
1 Oct 2019
Reported
9 Oct 2019
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Sterility

Timeline

12 Sep 2019Recall initiated by company
1 Oct 2019Classified by FDA+19 days
9 Oct 2019Published in enforcement report+8 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

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

Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

All lots remaining within expiry.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

79 other products · FDA event 83789

This product is part of a recall event; the main page for the event is GLYCOpyrrolate (PF) 0.6 mg/ (0.2 mg/mL) in Single Dose Syringe recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIGLYCOpyrrolate (PF) 0.6 mg/ (0.2 mg/mL) in Single Dose Syringe recalledKRS Global BiotechnologySterilityNationwide
CLASS IINEOstigmine Methylsulfate (PF), 5 mg/ (1 mg/mL) fill recalledKRS Global BiotechnologySterilityNationwide
CLASS IIQuadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl recalledKRS Global BiotechnologySterilityNationwide
CLASS IISermorelin, 3 mg / Ghrp-2, 3 mg / Vial, For SC Use-Lyophilized recalledKRS Global BiotechnologySterilityNationwide
CLASS IIVitamin 9A/B Lyophilized, Vial For IM Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IICyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl recalledKRS Global BiotechnologySterilityNationwide
CLASS IIL-Carnitine Fill in a Vial, For Dilution Use Only recalledKRS Global BiotechnologySterilityNationwide
CLASS IINEOstigmine Methylsulfate (PF), 3 mg/ (1 mg/mL) Single Dose Syringe recalledKRS Global BiotechnologySterilityNationwide
CLASS IIAscorbic Acid (Tapioca Source)/mL) Vial--For SC/IM recalledKRS Global BiotechnologySterilityNationwide
CLASS IIHydroxocobalamin 30 mg/ (1 mg/mL) Vial For IM Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIIsoproterenol HCL (PF) in D5W, 200 mcg / (4 mcg/mL) IV recalledKRS Global BiotechnologySterilityNationwide
CLASS IIPhenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl recalledKRS Global BiotechnologySterilityNationwide
CLASS IINORepinephrine in 0.9% Sodium Chloride (PF) IV, 4 mg/ (0.016 mg/mL) recalledKRS Global BiotechnologySterilityNationwide
CLASS IISodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. vial recalledKRS Global BiotechnologySterilityNationwide
CLASS IISodium Bicarbonate 8.4%, 4,200 mg / 50 mEq / (84 mg/mL) recalledKRS Global BiotechnologySterilityNationwide
CLASS IIBacteriostatic Water for Injection Vial recalledKRS Global BiotechnologySterilityNationwide
CLASS IISermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized recalledKRS Global BiotechnologySterilityNationwide
CLASS IILabetalol HCl 5 mg/mL 20 mg/ (5 mg/mL) Fill in a Single Dose Syringe recalledKRS Global BiotechnologySterilityNationwide
CLASS IILIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine recalledKRS Global BiotechnologySterilityNationwide
CLASS IIHydroxocobalamin Vial 5 mg/ (0.5 mg/mL) For IM Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIPHENYephrine HCl in 0.9% Sodium Chloride (PF) recalledKRS Global BiotechnologySterilityNationwide
CLASS IIPolidocanol 5%, 500 mg / (50 mg/mL) Vial for IV Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIMethionine 750 mg / Inositol 1,500 mg / Choline Chloride recalledKRS Global BiotechnologySterilityNationwide
CLASS IIFluorescein (PF) Lyophilized-For IV Use, Single Dose Vial recalledKRS Global BiotechnologySterilityNationwide
CLASS IICyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl recalledKRS Global BiotechnologySterilityNationwide
CLASS IIHuman Chorionic Gonadotropins Lyophilized For SC/IM Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIfentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg recalledKRS Global BiotechnologySterilityNationwide
CLASS IIHyaluronidase (PF) Ophthalmic Injection/mL) Fill recalledKRS Global BiotechnologySterilityNationwide
CLASS IIHuman Chorionic Gonadotropins Lyophilized For SC/IM Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIVitamin B1/B2/B3/B6/Hydroxocobalamin 66/1.33/66/66/0.66 recalledKRS Global BiotechnologySterilityNationwide
CLASS IIOxyTOCIN in 0.9% Sodium Chloride Solution (PF) / mL) Single Dose IV recalledKRS Global BiotechnologySterilityNationwide
CLASS IIfentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg recalledKRS Global BiotechnologySterilityNationwide
CLASS IIHydroxocobalamin 10 mg/ (0.5 mg/mL) fill in a Vial recalledKRS Global BiotechnologySterilityNationwide
CLASS IIfentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg recalledKRS Global BiotechnologySterilityNationwide
CLASS IINicotinamide Adenine Dinucleotide (PF) recalledKRS Global BiotechnologySterilityNationwide
CLASS IIKetamine in 0.9% Sodium Chloride (PF) 10 mg/mL fill in a Syringe recalledKRS Global BiotechnologySterilityNationwide
CLASS IIBimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate recalledKRS Global BiotechnologySterilityNationwide
CLASS IIMoxifloxacin 0.1% in BSS, Ophthalmic Injection recalledKRS Global BiotechnologySterilityNationwide
CLASS IIPHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) recalledKRS Global BiotechnologySterilityNationwide
CLASS IIAscorbic Acid (Tapioca Source) recalled by KRS Global BiotechnologyKRS Global BiotechnologySterilityNationwide
CLASS IICyclopentolate HCl 1% (5 mg/ / Phenylephrine HCl recalledKRS Global BiotechnologySterilityNationwide
CLASS IIVitamin 10 B Lyophilized, Vial, For IM Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg recalledKRS Global BiotechnologySterilityNationwide
CLASS IIGLYCOpyrrolate (PF) 1 mg/ (0.2 mg/mL) Fill in a Single Dose Syringe recalledKRS Global BiotechnologySterilityNationwide
CLASS IISermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIVitamin 5 B Vial For IM Use recalled by KRS Global BiotechnologyKRS Global BiotechnologySterilityNationwide
CLASS IISUCCinylcholine Chloride (PF), 100 mg / (20 mg/mL) Fill recalledKRS Global BiotechnologySterilityNationwide
CLASS IISUCCinylcholine Chloride (PF), 140 mg/ (20 mg/mL) Fill recalledKRS Global BiotechnologySterilityNationwide
CLASS IIePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg recalledKRS Global BiotechnologySterilityNationwide
CLASS IISermorelin Acetate 9 mg/ (3 mg/mL) recalled by KRS Global BiotechnologyKRS Global BiotechnologySterilityNationwide
CLASS IISermorelin Acetate, 9 mg / Ghrp recalled by KRS Global BiotechnologyKRS Global BiotechnologySterilityNationwide
CLASS IILIDOcaine 2% (20 mg/mL)/Bupivacaine recalled by KRS Global BiotechnologyKRS Global BiotechnologySterilityNationwide
CLASS IIMoxifloxacin 0.1% in BSS, Ophthalmic Injection recalledKRS Global BiotechnologySterilityNationwide
CLASS IIPHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg recalledKRS Global BiotechnologySterilityNationwide
CLASS IISermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2 recalledKRS Global BiotechnologySterilityNationwide
CLASS IILidocaine HCl 30 mg/mL/Hyaluronidase/mL (PF) Fill recalledKRS Global BiotechnologySterilityNationwide
CLASS IIAlpha Lipoic Acid (PF) 750 mg recalled by KRS Global BiotechnologyKRS Global BiotechnologySterilityNationwide
CLASS IIVitamin 9 Lyophilized, Vial For IM Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIQuadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl recalledKRS Global BiotechnologySterilityNationwide
CLASS IIGlutathione Vial-For IM Use-Hypertonic solution, 6,000 mg recalledKRS Global BiotechnologySterilityNationwide
CLASS IIVitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIL-Asparaginase Lyophilized, 10,000 International Units/Vial recalledKRS Global BiotechnologySterilityNationwide
CLASS IICyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl recalledKRS Global BiotechnologySterilityNationwide
CLASS IISermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg recalledKRS Global BiotechnologySterilityNationwide
CLASS IIKetamine in 0.9% Sodium Chloride (PF) 50 mg recalledKRS Global BiotechnologySterilityNationwide
CLASS IIHuman Chorionic Gonadotropins Lyophilized For SC/IM Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IIPHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites) recalledKRS Global BiotechnologySterilityNationwide
CLASS IIMagnesium Chloride Hexahydrate 82.5 mg/mL recalledKRS Global BiotechnologySterilityNationwide
CLASS IIPHENYephrine HCl in 0.9% Sodium Chloride (PF) recalledKRS Global BiotechnologySterilityNationwide
CLASS IIL-Carnitine in a Vial, 4,590 mg/ (170 mg/mL) recalledKRS Global BiotechnologySterilityNationwide
CLASS IIePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg recalledKRS Global BiotechnologySterilityNationwide
CLASS IILIDOcaine HCl 1% (PF) 50 mg/ (10 mg/mL) Fill recalledKRS Global BiotechnologySterilityNationwide
CLASS IINORepinephrine in 0.9% Sodium Chloride (PF) IV, 8 mg/ (0.032 mg/mL) recalledKRS Global BiotechnologySterilityNationwide
CLASS IIMethylcobalamin Vial-For SC / IM / IV Use, 30 mg / (1 mg / mL) recalledKRS Global BiotechnologySterilityNationwide
CLASS IICyclopentolate HCl 1% (5 mg/ / Phenylephrine HCl recalledKRS Global BiotechnologySterilityNationwide
CLASS IIHuman Chorionic Gonadotropins Lyophilized For SC/IM Use recalledKRS Global BiotechnologySterilityNationwide
CLASS IISUCCinylcholine Chloride (PF), 200 mg/ (20 mg/mL) Fill recalledKRS Global BiotechnologySterilityNationwide
CLASS IINorepinephrine added to 5% Dextrose (PF) IV, 8 mg/ (0.032 mg/mL) recalledKRS Global BiotechnologySterilityNationwide
CLASS IILIDOcaine HCl 2% (PF) 100 mg/ (20 mg/mL) Fill recalledKRS Global BiotechnologySterilityNationwide

More recalls from KRS Global Biotechnology

All 129
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILIDOcaine HCl 2% (PF) 100 mg/ (20 mg/mL) Fill recalledKRS Global BiotechnologySterilityNationwide
DrugCLASS IINorepinephrine added to 5% Dextrose (PF) IV, 8 mg/ (0.032 mg/mL) recalledKRS Global BiotechnologySterilityNationwide
DrugCLASS IISUCCinylcholine Chloride (PF), 200 mg/ (20 mg/mL) Fill recalledKRS Global BiotechnologySterilityNationwide
DrugCLASS IIHuman Chorionic Gonadotropins Lyophilized For SC/IM Use recalledKRS Global BiotechnologySterilityNationwide
DrugCLASS IICyclopentolate HCl 1% (5 mg/ / Phenylephrine HCl recalledKRS Global BiotechnologySterilityNationwide

Other Sermorelin recalls

All 74
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISermorelin Acetate 1 MG/ML Injectable syringes recalledCarolina InfusionSterilityNationwide
DrugCLASS IISermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
DrugCLASS IISermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
DrugCLASS IISermorelin 2000mcg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
DrugCLASS IISermorelin Acetate, Lyophilized powder for reconstitution recalledOlympia Compounding PharmacyManufacturing (CGMP) DeviationsNationwide