New Nationwide Compounding Pharmacy Recall Initiated

A New Jersey compounding pharmacy this weekend issued a voluntary nationwide recall of all lots of all products compounded at its facility due to potential mold contamination, according to an FDA alert. The list of products being recalled by Medprep Consulting Inc., of Tinton Falls, N.J., includes a variety of antibiotic and anesthetic/analgesic solutions.

A Connecticut hospital notified Medprep after it observed visible particulate contaminants in 50 ml bags of magnesium sulfate 2 grams in dextrose 5% for injection IV solution that was later confirmed to be mold. Five contaminated bags were discovered and so the recall began on Saturday only with all lots of magnesium sulfate 2 grams in dextrose 5% for injection products compounded at its facility. It was upgraded to include 84 compounded products, including bupivacaine, cefazolin, clindamycin, fentanyl citrate, gentamicin, heparin, midazolam, ropivacaine and succinylcholine.

Medprep previously received warning letters regarding sterility and manufacturing processes from the FDA in 2001 and 2010. No injuries or illnesses related to the mold contamination have been reported, according to the FDA.

In the fungal meningitis outbreak traced to contaminated steroid injections produced by New England Compounding Center, 50 patients have died and 722 have been infected. The CDC has issued updated guidance about that outbreak, noting that infections continue to occur and that clinicians should "remain vigilant for fungal infections, especially in patients with mild or even baseline symptoms."

Stephanie Wasek