Dec 10, 2020
Gizmodo – Pharmaceutical company AvKare issued recalls on Wednesday after pills were inadvertently mixed during bottling, according to the FDA.
The generic drugs being recalled are sildenafil, used to treat erectile dysfunction, and trazodone, an antidepressant and sedative.
Unintentionally taking sildenafil may be dangerous for some patients because it can lower blood pressure and interact badly with other medications, especially people who take nitrates to treat conditions like diabetes, high blood pressure, and heart disease, the FDA warns.
Sildenafil is the active ingredient in brand-name Viagra.
But it’s also concerning that some people, especially elderly patients, might be getting an antidepressant when they’re trying to get an erection. Trazodone, which is used to treat major depressive disorders and anxiety, can cause sedation, dizziness, constipation, and blurred vision according to the FDA.
Travadone tablets, which look nothing like sildenafil tablets, are round:
Sildenafil tablets are oval:
Anyone in possession of medications with the following identifiers should not consume them:
AvKare, based in Tennessee, has a number of contracts with the U.S. government, including the Department of Defense and the Department of Veterans Affairs.
ORIGINAL PRESS RELEASE:
AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets due to Product Mix-up
FOR IMMEDIATE RELEASE – December 7, 2020
AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility.
|Product||Lot||Expiration date||Bottle count||NDC Number|
|Sildenafil Tablets, USP||36884||03/2022||100||42291-748-01|
|Trazodone Tablets, USP||36783||06/2022||1000||42291-834-10|
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. 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. To date, AvKARE has not received any reports of adverse events related to this recall.
Sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor, is used for the treatment of erectile dysfunction and is packaged in 100 count bottles, NDC 42291-748-01. Trazodone hydrochloride is indicated for the treatment of major depressive disorder and packaged in 1000 count bottles, NDC 42291-834-10. The affected lots of 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) were distributed to our distributors and wholesalers, and then further distributed nationwide.
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.
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: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.