Sterility Concerns Spark Altaire's CVS, Walmart, Walgreens Eye Drop Recalls
Executive Summary
Altaire "is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility," firm says in its recall announcements.
Concerns that insufficient manufacturing quality controls could render its ophthalmic products non-sterile prompted Altaire Pharmaceuticals Inc. to recall nearly 270 lots of store-brand OTCs sold by CVS Health Corp., [Wal-Mart Stores Inc.] and Walgreen Co..
In its latest announcement about the recalls, concerning CVS Health products, Altaire said the US Food and Drug Administration "has determined these issues indicate a lack of sterility assurance."
Altaire on 10 July notified CVS about 189 lots of CVS Health brand eye drops, gels and ointments and on 2 July notified Walmart about 73 lots of Equate brand and one lot of Support Harmony and Walgreens about six lots of products sold in its stores.
The products are labeled with indications for lubrication and allergy, dryness or redness relief and are formulated in multiple strengths and for day or night use (see chart linked below for lot numbers and other information on Altaire's 269-product OTC recall).
"As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility," said the firm in its recall announcements published by the FDA.
The Riverhead, NY-based firm on 3 July notified manufacturer Perrigo Co. PLC about 70 lots of Rx ophthalmic products it provided. It asked the retailers to inform customers about the recalled lots, and asked Perrigo to recall products from the lots that it shipped to its retailer and distributor customers.
Altaire Pharmaceuticals Private Label And Store Brand Ophthalmic Product Recalls
Altaire, which also market its own NanoTears brand of ophthalmic products, said in its announcement that has received no reports of adverse events nor has it obtained out-of-specifications results, including sterility testing, for the products.
The firm in 2013 recalled a total of nearly 364,000 bottles of carboxymethylcellulose sodium 0.5% ophthalmic solution in 1-fluid ounce (30 mL) bottles it provided CVS Pharmacy Inc., Walmart and Target Corp. The recall came after customer complaints of mold, which may have been caused by the preservative used in the lots not remaining effective through expiry. (Also see "FDA Recalls For Dec. 25, 2013" - HBW Insight, 6 Jan, 2014.)
Other OTC private label and store brand manufacturers also recently reported recalls, including a Sun Pharmaceutical Industries Ltd. business, P&L Developments LLC and Preferred Pharmaceutical Inc. (Also see "Store Brand Cough/Cold OTCs, Alterna Conditioners Among Recent Recalls" - HBW Insight, 27 Jun, 2019.)
Additionally, the latest updates to the FDA's recalls database include store brand OTC acetaminophen children's liquid and diphenhydramine liquid manufactured by Torrent Pharma Inc. (see chart linked below).
Health, Beauty And Wellness Product Recalls: 3 July, 2019