The company’s manufacturing facility, located in New York, US, produces the affected lots of product, including bacitracin ophthalmic ointment and sulfacetamide sodium ophthalmic ointment.
In total, seven different products are being recalled due to worries that the products may not be sterile – though Altaire Pharmaceuticals specified that, to date, it has received no evidence of out-of-specification results for its products.
A statement from the company explained the reasons behind the recall: “Altaire is initiating the recall due to management concerns regarding the sufficiency of quality assurance (QA) controls over critical systems in the manufacturing facility.”
The products recalled include neomycin and polymixin B and bacitracin zinc ophthalmic ointment; neomycin and polymixin B and dexamethasone ophthalmic ointment; neomycin and polymixin B and bacitracin zinc and hydrocortisone acetate ophthalmic ointment; polymixin B and bacitracin zinc ophthalmic ointment; bacitracin ophthalmic ointment; sulfacetamide sodium ophthalmic ointment, and puralube ophthalmic ointment.
Altaire produces and labels the products exclusively for Perrigo Company, which then distributes the products to the retail level. Perrigo will perform a subrecall of the products and notify its customers.
In 2013, the company was involved in a recall of over 363,000 bottles of carboxymethylcellulose sodium 0.5% ophthalmic solution due to the presence of mold being found in the bottles. The products had reached the consumer level in the US and had been stocked in CVS, Target and Wal-Mart.
Additional OTC recall
The day following the announcement that the company would be recalling prescription drug products, Altaire issued a further voluntary recall for over-the-counter (OTC) drug products.
There are 16 affected products stocked at Walgreens and Wal-Mart, all of which are ophthalmic products.
The reasons given for the recall are the same as for the prescription products, with the company indicating that potential QA issues meant that there could potentially be sterility issues – though it specified that there have yet to be any reports of adverse events in relation to this additional recall.
The list of products includes lubricant eye drops and sodium chloride ophthalmic ointment.