Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Ha
Manufacturer / Brand: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Date Issued
Category
Medications
Status
unknown
Issuing Agency
FDA CDER
About fire and burn hazards
Fire and burn hazards in consumer products are often caused by overheating lithium-ion batteries, faulty electrical wiring, flammable materials used in construction, or manufacturing defects that create short circuits. These recalls are classified as urgent because fire and burn injuries can occur rapidly, often without warning. Overheating batteries in particular can enter a state called thermal runaway, which generates intense heat and can cause a fire even when a device appears to be functioning normally.
⚠ Stop using the product immediately and do not charge it if it is battery-powered. Keep it away from flammable materials and in a cool, well-ventilated area until you can safely dispose of or return it.
What to do if you're affected
- →Stop using the product and disconnect it from any power source immediately.
- →Do not charge the product if it is battery-powered.
- →Keep the product away from flammable materials in a ventilated area until you can return or dispose of it.
- →Follow the manufacturer's instructions in the recall notice for the return or refund process.
- →Do not attempt to disassemble a product recalled for fire or battery hazards.
About the FDA CDER
This recall was issued by or conducted in cooperation with the FDA's Center for Drug Evaluation and Research (CDER), which oversees prescription and over-the-counter medications sold in the United States. Drug recalls may be initiated voluntarily by the manufacturer or at FDA's request after a quality problem is identified through manufacturer testing, FDA inspection, or adverse event reports. Recalls are classified by severity: Class I involves products that may cause serious injury or death; Class II and III involve lower levels of risk. Do not stop a prescription medication due to a recall without first consulting your doctor or pharmacist.
View all FDA CDER recalls →Opens the official government source. Always refer to official sources for the most current information.