Class II · Moderate risk Terminated
Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10
Reason cGMP deviations: Temperature abuse
Is Bicarbonate recalled?
113 FDA recalls mention Bicarbonate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bicarbonate.
Class II · Moderate risk Terminated
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho…
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho…
Reason Non-Sterility: firm's third party lab confirmed microbial contamination.
Class II · Moderate risk Terminated
Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SODIUM BICARBONATE 8.4% (1 MEQ/ML) INJ SOLN (PFV), 50 ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial…
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Class II · Moderate risk Terminated
DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderson Compounding Pharmacy 310 Bluff City…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL Syringe, Anderson Compounding Pharmacy 310 Bluff…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Anderson Compounding…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Anderson Compounding…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by…
Reason Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per…
Reason Presence of Particulate Matter; glass particulates
Class II · Moderate risk Terminated
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered…
Reason Subpotent
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