Regulatory Updates

The FDA has initiated a recall of a product because of deviations from current Good Manufacturing Practices (CGMP).

The FDA has issued a recall for bottles labeled with an incorrect expiry date of 11/2016; the correct date should be 09/2016.

The FDA has issued a recall for sterile injectable drugs after detecting glass particulate contamination in the active pharmaceutical ingredient.

The FDA has issued a recall for products manufactured with a contaminated excipient that was previously recalled by the supplier, citing CGMP deviations.

The FDA reports that certain bottles may contain mixed strengths of the product, prompting a recall.

FDA recalls Next Advanced Antibacterial Hand Sanitizer due to ethanol below label claim and methanol contamination; related products from the same plant also withdrawn.

The FDA is initiating a recall of all compounded sterile preparations still within their expiration dates because poor sterile production practices have compromised sterility assurance.

Crescent Pharma Limited is recalling a batch of Ramipril 10mg capsules as a precaution due to a possible manufacturing error.

Omega Pharma Ltd is recalling specific batches of Napralief 250mg gastro‑resistant tablets because sections of the patient information leaflet and carton labeling are missing.

Amarox Limited is recalling a batch of 100 mg film‑coated sertraline tablets due to a manufacturing site error.

Crescent Pharma Limited is recalling a batch of 2.5 mg Ramipril capsules due to a possible packaging error.

Edwards reports mislabelled sensor cables on the ForeSight™ Oximeter Cable may cause swapped left/right StO2 values, risking misdiagnosis.