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.

Four years after a FDA rejection, Spero Therapeutics and GSK have moved their oral UTI drug Utebzi closer to approval.

The FDA approved ANDA076320 for a prescription topical cream containing 2.5% lidocaine and 2.5% prilocaine, manufactured by Encube Ethicals.

FDA granted tentative approval to Hikma Pharm's ANDA078658 for three oral rosiglitazone maleate tablet strengths (2 mg, 4 mg, 8 mg).

The FDA has approved Dr. Reddy's Laboratories' DESLORATADINE oral disintegrating tablets in 2.5 mg and 5 mg strengths under ANDA 078367.

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Hand Sanitizer due to ethanol below label claim and methanol contamination; related products from the same plant also withdrawn.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

Colorado has been cleared by the FDA to pursue its own drug import strategy, though practical implementation may be challenging.