Bone Screw Recall – Calaxo Screws

Smith & Nephew Inc. is recalling all lot numbers and all item codes of CALAXO screws which were
first distributed in the UK in 2006. This screw is used to secure the graft in anterior cruciate
ligament (ACL) reconstruction.

Worldwide, 0.3% of patients have developed pre-tibial soft tissue swelling, which can mimic the
appearance of an infection between 2 and 36 weeks after implantation. The manufacturer is
currently investigating the cause of this problem.

Most cases resolved without intervention. A small number of cases needed local debridement and
removal of any remaining screw fragments, or replacement with an alternative screw or bone graft.
The manufacturer estimates that about 2,550 devices have been used in the UK since 2006.
The manufacturer is aware of seven reported cases of inflammation in the UK of which two
required implant revision.

The manufacturer wrote to chief executive officers of trusts, theatre managers, and surgeons who
were known to use CALAXO about this product recall in August 2007 (see MHRA website). This
notice is to facilitate the recall.

Digoxin Recall – Caraco Brand

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.

The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure.

Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability.

Consumers with the recalled product should return these products to their pharmacy or place of purchase.