Class II · Moderate risk Terminated
8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per…
Reason Lack of Assurance of Sterility
Is Carbo recalled?
243 FDA recalls mention Carbo. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Carbo.
Class II · Moderate risk Terminated
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional…
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155…
Reason Lack of assurance of sterility.
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
Class II · Moderate risk Terminated
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI…
Reason cGMP deviations
Class II · Moderate risk Terminated
Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Reason cGMP deviations
Class II · Moderate risk Terminated
MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Reason cGMP deviations
Class II · Moderate risk Terminated
Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC…
Reason cGMP deviations
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
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer…
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc…
Reason Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Class II · Moderate risk Terminated
ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum…
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum 10X…
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X…
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Crataegus…
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
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