2013

The potential presence of a placebo instead of the drug itself in a portion of the product has prompted the recall of Estarylla tablets by Sandoz.  The drug, an oral contraceptive, is being recalled on the heels of a user reporting that, within the row of actual tablets, there was a placebo.  The company notes… read more

Last year, a fungal meningitis outbreak claimed the lives of numerous citizens from around the country and compromised the safety and health of many more.  The Food and Drug Administration ratcheted up their compounding pharmacy regulatory efforts as a result, conducting a series of inspections that even led to 14 recalls.  These were issued due… read more

The possible inclusion of small pieces of glass within the product has led to the recall of Benztropine Mesylate Injection in 2 mg/mL single dose vials.  Fresenius Kabi USA announced the recall, which affects four lots of product (030712, 071212, 090512, and 111412).  Although no one has reported experiencing any type of adversity at this… read more

A potential mixup in the product contained within the bottle has led to a recall from the Holtsville, New York-based Advance Pharmaceutical.  Bottles of Enteric Coated Aspirin Tablets 81 mg under the Rugby label from Lot 13A026 and with an expiration date of January 2015 might in fact contain 500 mg tablets of acetaminophen.  Because… read more

Vecuronium Bromide for Injection 10mg is being recalled by the Schaumburg, Illinois-based Sagent Pharmaceuticals due to an issue that has the potential to have a distinct impact on patient safety.  Three lots are affected by the recall, and each was provided to Sagent by MN Pharmaceuticals and then made available to hospitals and further distributors… read more

Sterile compounded drugs are being recalled again, this time by the Newbern, Tennessee-based Main Street Family Pharmacy.  All lots of these items, which were made available to doctors and patients across the country, are affected by the recall, and adverse events have already been reported in conjunction with products from three of those lots.  In… read more

The potential for particulate formation has prompted Sandoz to announce the recall of Methotrexate Sodium Injections available across the country and in Poland.  Lot CL0996 and Lot CJ4948 are impacted by the recall, which was initiated once a quality test of a sample product identified the presence of particulates.  If the drug, which is typically… read more

All sterile products manufactured by the St. Petersburg, Florida-based The Compounding Shop are being recalled because said sterility cannot be guaranteed.  The move was made following a Food and Drug Administration inspection of the company’s facilities that highlighted conditions which could lead to the sterility of the compounded items being compromised.  This is the latest… read more

Versions of Piperacillin and Tazobactam for Injection, USP 40.5 grams with expiration dates ranging from this month to April of next year are being recalled by Apotex Corporation and Hospira because of a possible threat to patient health.  In 15 lots of this product, the IV line or bag could sustain crystallization or precipitation, a… read more

More sterile compounded products are being recalled, this time by the Indianapolis, Indiana-based Nora Apothecary & Alternative Therapies.  The recall pertains to those items that were produced prior to this past Friday and that have yet to expire.  The Food and Drug Administration recently carried out an inspection which revealed deficiencies in the company’s quality… read more

All sterile compounded items that have yet to expire have been recalled by Balanced Solutions Compounding Pharmacy after a Food and Drug Administration inspection ascertained the presence of gram negative bacteria in a chromium chloride injection.  That product had already been recalled, but in order to protect patients, this all-encompassing recall has been issued, as… read more

You can add two more compounders to the list of those that have had to recall products due to a perceived lack of assured sterility.  These latest two recalls come on the heels of inspections by the Food and Drug Administration that revealed the potential contamination danger. The first recall was issued by ApotheCure Inc…. read more