FDA Recall
Terminated
Historical recordClass II
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01
by Pfizer Inc.
- Reason
- Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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