Class II · Moderate risk Terminated
LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG…
Reason Lack of Assurance of Sterility
Is Benzyl recalled?
56 FDA recalls mention Benzyl. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Benzyl.
Class II · Moderate risk Terminated
LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg…
Reason Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
Class II · Moderate risk Terminated
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg…
Reason Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V…
Reason Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class II · Moderate risk Terminated
PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium…
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk Terminated
METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium…
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk Terminated
Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted…
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk Terminated
MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg…
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk Terminated
Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl…
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk Terminated
CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl…
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I · High risk Terminated
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol…
Reason Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial…
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient…
Reason Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Class II · Moderate risk Terminated
Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183
Reason Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial…
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