A Tennessee-based pharmaceutical firm introduced Wednesday that it’s “voluntarily recalling” two medicine – one which treats erectile dysfunction, the opposite depression – after a “product mix-up” that resulted within the medications being “inadvertently packaged collectively” after they had been bottled at a 3rd-get together facility.
AvKARE, which is headquartered in Pulaski, Tenn., is recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the buyer stage, the corporate stated in an announcement reposted to the U.S. Meals and Drug Administration’s web site.
Sildenafil is the energetic ingredient in Viagra, which is a PDE-5 inhibitor, and is used for the remedy of erectile dysfunction and is packaged in 100-depend bottles, the corporate stated.
Unintentional consumption of Sildenafil could pose severe well being dangers to customers with underlying medical points, in line with AvKARE. For instance, Sildenafil could work together with nitrates present in some prescribed drugs, resembling nitroglycerin, decreasing blood strain to harmful ranges. Customers with diabetes, hypertension or coronary heart illness typically take nitrates.
The corporate stated Trazodone hydrochloride is indicated for the remedy of main depressive dysfunction and packaged in 1,000- depend bottles.
Unintended consumption of Trazodone could lead to antagonistic well being penalties, resembling somnolence/sedation, dizziness, constipation and blurred imaginative and prescient – all antagonistic occasions which may be extra regarding in aged sufferers because of a subsequent elevated threat for falls and driving impairment, in line with AvKARE.
The affected a number of Sildenafil 100 mg Pill — Lot 36884 with an expiration date of 03/2022 — and Trazodone Hydrochloride 100 mg Pill — Lot 36783 with an expiration date of 06/2022 – “had been distributed to our distributors and wholesalers, after which additional distributed nationwide,” the corporate stated.
AvKARE added that it “notified its distributors and clients and is arranging for return of all recalled product of the listed heaps.”
On the time the press launch was printed Wednesday, AvKARE had not obtained any reviews of antagonistic occasions associated to this recall.
It suggested any shopper who believes they’ve skilled any issues associated to taking these medicine to contact their doctor or well being care supplier. Antagonistic reactions or high quality issues skilled with the usage of this product could also be reported to the FDA’s MedWatch Antagonistic Occasion Reporting program both on-line, by common mail or by fax.