Weekly FDA Enforcement Report For Drugs 9/10/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for September 10, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Classification.

Classification I Drug Recall

A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.

No Class I recalls this week.

Classification II Drug Recall

A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.

• Apotex, one of the largest pharmaceutical companies in Canada, recalled several products manufactured by GlaxoSmithKline. Recalled products include Paxil (Paroxetine HCL) Controlled-Release Tablets 12.5 mg/25 mg/37.5 and Oral Suspension 10 mg/5 mL. Paxil is a selective serotonin reuptake inhibitor (SSRI) used for psychiatric purposes including depression, anxiety, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).The voluntary recall nationwide and to Puerto Rico was due to chemical contamination. The products were manufactured with active pharmaceutical ingredient (API) batches that were contaminated with residual materials and solvents.

In August, Apotex issued a news release announcing the recall of Apo-Mycophenolic Acid, an organ-rejection drug. The company recalled the product, in consultation with Health Canada, due to a labeling error. The tablets were 360 mg but were labeled as 180 mg. An overdose of the drug might suppress the immune system, leading to infection or possibly death.

• Sage Products from Cary, IL recalled Comfort Shield Barrier Cream Cloths with dimethicone (8 and 24 count) due to bacterial contamination. The products are used for incontinence care. Dimethicone, the active therapeutic, helps prevent or treat skin irritations.
• Qualitest Pharmaceuticals from Huntsville, AL recalled Oxycodone/Acetaminophen (10 mg/325 mg) because broken tablets were found in sealed bottles. Qualitest is part of Endo International. The company’s U.S. headquarters are in Malvern, PA and global headquarters are in Dublin, Ireland. Its three manufacturing facilities in Huntsville include facilities for manufacturing and packaging of liquids and solid dose products.

Classification III Drug Recall

A Classification III recall signifies that the product is not likely to cause adverse health consequences.

No Class III recalls this week.