Pharmaceutical distributor AvKare is voluntarily recalling 100mg sildenafil tablets and 100mg trazodone tablets due to a "product mix-up," the company just announced.
The tablets were "inadvertently packaged together" when they were bottled by a third-party vendor.
Sildenafil is the active ingredient in Viagra, which is used for the treatment of erectile dysfunction.
Trazodone is used to treat major depressive disorder.
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Talk about a mix-up! When you think you're taking a drug to make you feel better, you may be taking something to increase blood flow to your reproductive organs.
While it may sound funny at first, the results can actually be serious.
According to the FDA, unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues.
For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels.
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Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
Unintended intake of trazodone may result in adverse health consequences such as somnolence/sedation, dizziness, constipation, and blurred vision.
These adverse events may be more concerning in elderly patients due to a subsequent increased risk for falls and driving impairment.
Unintentional intake of trazodone can result in sedation, dizziness, constipation and blurred vision.
So far, AvKare said, it has not received any reports of adverse events related to this recall.
AvKARE has notified its distributors and customers and is arranging for return of all recalled product of the listed lots.
Distributors that have any of the subject product which is being recalled should contact Customer Service at AvKARE at 1-855-361-3993 or email [email protected] to arrange for the return of the product.
Consumers with questions regarding this recall can contact AvKARE at 1-855-361-3993 Monday- Friday (8am – 4pm CST).
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
The specific lots that are being recalled are sildenafil 100 mg tablet Lot 36884 with an expiration date of 03/2022 and trazodone hydrochloride 100 mg tablet lot 36783 with an expiration date of 06/2022.
Consumers with questions about the recall can contact AvKARE at 1-855-361-3993 Monday- Friday (8am -- 4pm CST).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online here
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
