Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC…
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Dr. Reddy's Laboratories
- Product
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
- Classification
- Class II
- Units
- USA Nationwide.
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Dr. Reddy's Laboratories recalls
- 2024-12-18
USDr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,…
Failed Impurities/Degradation Specifications
- 2024-11-27
- US
- 2024-11-13
- US
Dr. Reddy's Laboratories, Inc. recalls Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC…
Failed Impurities/Degradation Specification
- 2024-09-04
- US
Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC…
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- 2024-08-14
- US
Dr. Reddy's Laboratories, Inc. recalls Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories…
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
- 2024-07-10
- US
Other drugs & medical recalls in the United States
- 2024-11-06
- US
Maquet Cardiovascular, LLC recalls VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution. US Nationwide. Brazil, China, and Hong Kong.Official notice → - US
ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15,…
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- US
BLI International, Inc. recalls Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Superpotent Drug: Stability failure for assay at 6 months test time-point.
FDA · DrugBLI International, Inc.Product was shipped to two private label customers ( OH & MO) as a final…Official notice → - 2024-10-30
- US
Boston Scientific Corporation recalls Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac…
Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
FDA · DeviceBoston Scientific CorporationNationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY,…Official notice → - US
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate…
Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon,…
FDA · DeviceOlympus Corporation of the AmericasWorldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA,…Official notice → - US
Spectrum Medical Ltd. recalls Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing.…
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
FDA · DeviceSpectrum Medical Ltd.US Nationwide distribution including in the states of Alabama, California,…Official notice →