Class II · Moderate risk Ongoing
Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Is Cyanocobalamin recalled?
73 FDA recalls mention Cyanocobalamin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cyanocobalamin.
Class II · Moderate risk Ongoing
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns…
Class II · Moderate risk Terminated
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Reason Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk Terminated
Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c)…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class II · Moderate risk Terminated
CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding…
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only…
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30 mL Multi-Dose Vial…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Class II · Moderate risk Terminated
Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Class II · Moderate risk Terminated
CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional…
Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk Terminated
CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 2000 unit/1mg/mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake…
Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk Terminated
CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 1000 units/1 mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake…
Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk Terminated
Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267…
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the…
Class II · Moderate risk Terminated
Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of…
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of…
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of…
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North…
Reason Lack of Assurance of Sterility
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