Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Microbial Contamination of Non-Sterile Product
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Drug: Ondansetron Category: Heartburn & Stomach Medication
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Failed pH Specifications
Lack of sterility assurance
Lack of assurance of sterility.
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
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