J&J’s prescription drugs unit hit by recall
pharmafile | September 17, 2013 | News story | Manufacturing and Production | J&J, JJ, Risperdal, Tylenol, recalls
Johnson & Johnson has been forced to issue yet another recall notice, this time affecting its big-selling prescription antipsychotic medication Risperdal Consta.
Most of J&J’s manufacturing woes have involved its over-the-counter (OTC) division McNeil, which continues to operate under an FDA consent decree it entered into in 2010, although a few recalls have affected its prescription drug and medical device businesses.
The latest recall on this occasion was prompted by the discovery of mould on some 25mg vials of Risperdal Consta (risperidone) during routine quality testing, and affects a single lot of around 70,000 units made in 2012.
“A stability sample tested positive for Alternaria alternata, a mould commonly found in the environment,” says J&J in the recall letter.
The presence of the mould could theoretically cause a localised infection at the injection site, an allergic reaction or potentially a systemic infection if the patient receiving the drug was immunocompromised, it adds.
However, “there have been no trends or patterns of clustering of adverse events of infection associated with the identified lot,” notes the company. J&J estimates that around 5,000 vials in the affected Risperdal Consta batch remain unused.
J&J continues to struggle with quality problems despite wide-ranging remediation activities across several of its plants, which have cost an estimated $100 million. Just last week the company recalled 200,000 bottles of a paediatric Motrin (ibuprofen) product because of contamination with plastic particles.
Other product recalls in brief
– Another company struggling with ongoing quality issues – Hospira – has issued yet another recall notice affecting one of its sterile injectable products. The company is fetching back two lots of its local anaesthetic product bupivacaine in single-dose vials due to reports of contamination with stainless steel and iron oxide particles.
– The FDA’s crackdown on compounding pharmacies continues apace, with recent recalls for bevacizumab and lidocaine/phenylephrine from Leiter’s Compounding Pharmacy, bevacizumab and vancomycin from Avella Speciality Pharmacy and various testosterone products from University Compounding Pharmacy. All the cases were related to a lack of sterility assurance. The agency has tightened its oversight of compounding pharmacies in the wake of a fungal meningitis outbreak caused by dubious production practices at the New England Compounding Pharmacy (NECC) that claimed more than 60 lives last year.
Phil Taylor
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