Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Stability data does not support expiry.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
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.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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