Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.