Class II · Moderate risk Completed
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose…
Reason Lack of assurance of sterility.
Is Ornithine recalled?
7 FDA recalls mention Ornithine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ornithine.
Class II · Moderate risk Ongoing
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE, Rx…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy…
Reason Lack of sterility assurance.
Class II · Moderate risk Ongoing
Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by…
Reason Lack of Assurance of Sterility
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