Consumers are on edge as the COVID-19 pandemic casts doubts on the quality of drugs reaching shelves around the world. On U.S. shores, experts say those issues are warranted—and a wave of Pfizer recalls for menopause drug Duavee won't help build confidence.
Pfizer voluntarily recalled two batches of Duavee––marketed as Duavive abroad––from U.K. shelves after identifying faulty packaging that may have reduced the drug's efficacy, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) said Monday.
Pfizer launched the recall after manufacturers identified a flaw in the drug's foil laminate pouch that introduced oxygen and lowered the dissolution rate of active pharmaceutical ingredient bazedoxifene acetate, the MHRA said.
The U.K. recalls comes just weeks after Pfizer voluntarily withdrew 11 lots of Duavee in the U.S. at the wholesaler level and two in Canada in late May, a Pfizer spokeswoman said.
The two recalled U.K. batches of 28-pack Duavive tablets expire in September 2020 and August 2021. Any remaining consumer stock should be quarantined and sent back to Pfizer for reimbursement, according to the MHRA.
In a recall notice dated May 20, Health Canada said Pfizer Canada would pull two affected lots of Duavive for issues with bazedoxifene dissolution.
The agency classified the recall as a Class II hazard, meaning "a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote."
Duavee received an FDA approval in 2013 as a treatment for symptoms associated with menopause and osteoporosis.
Pfizer's recalls come as consumers grow increasingly concerned about drug quality during the COVID-19 pandemic.
Last week, independent testing laboratory Valisure's CEO David Light testified to U.S. senators that the pandemic would likely put a strain on the FDA's ability to adequately test the quality of drugs produced in foreign plants.
The FDA has maintained an effective ban on foreign inspections since March, only venturing inspectors into foreign manufacturing facilities for high-priority check-ins.
Meanwhile, the FDA in early June asked five drugmakers to voluntarily withdraw their versions of commonly used diabetes drug metformin off shelves after the agency identified high levels of NDMA contamination in tested lots.