Class II · Moderate risk Terminated
Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON…
Reason Lack of Assurance of Sterility
Is Midazolam recalled?
43 FDA recalls mention Midazolam. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Midazolam.
Class II · Moderate risk Terminated
Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC #…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock…
Reason Subpotent Drug
Class II · Moderate risk Terminated
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721
Reason Subpotent Drug
Class II · Moderate risk Terminated
Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON…
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON…
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON…
Reason Subpotent drug.
Class II · Moderate risk Terminated
Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf…
Reason Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Class II · Moderate risk Terminated
midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only…
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk Terminated
midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only…
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk Terminated
midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class I · High risk Terminated
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals…
Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk Terminated
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd…
Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk Terminated
Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc…
Reason Superpotent Drug: Product contains twice the stated amount of midazolam.
Class II · Moderate risk Terminated
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg…
Reason Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk Terminated
MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
Class II · Moderate risk Terminated
Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured…
Reason Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
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