Labeling problems can lead to a recall, particularly when a drug is missing its expiration date labels--or some of the paper label pieces end up in vials. That is the scenario Mylan ($MYL) faces in recalling products made by Agila Specialties, the injectable drug company it bought last year for $1.7 billion.
The drugmaker sent a letter to customers Thursday saying it was recalling 10 lots of the injectable "hypnotic drug" etomidate in 2-, 10- and 20-mL doses. The Pittsburgh-based drugmaker said that the cartons and the vials may be missing lot numbers and expiry dates or they may be illegible on the vials. The vials may also have black particulate in them, which the company said was identified as paper shipper labels. The product was made for Pfizer ($PFE).
The products were manufactured by an Agila Specialties Polska plant in Warsaw, Poland. That is not the same Agila plant that the FDA issued a warning letter to last year. That enforcement action was against an Agila Specialties plant in Bangalore, India, and was sent before Mylan completed the buyout of Agila from India's Strides Arcolab. The plant was chastised for using defective gloves in the aseptic processing area and then not taking the problems seriously enough. Mylan closed its deal with Strides in December but held back $250 million until the regulatory issues get resolved.
It is not uncommon for injectable drugs to be recalled because of particulates. Hospira ($HSP) recalled some lots of bupivacaine injection last year after particles of stainless steel and iron oxide were discovered embedded in the glass, a problem that was tracked back to the glass supplier. It recalled a lot of a parenteral nutritional product after a human hair was found in an injector. Baxter International ($BAX) issued recalls in December and January after particulates were discovered in some of its sterile injectable products.
- here's the announcement