Drug Company Recalls Sildenafil And Trazodone After Bottling Mix-Up
Image: FDA
A drug company has begun a nationwide recall of Sildenafil and Trazodone tablets because they were apparently packaged together.
AvKARE of Pulaski, Tennessee, is recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets due after learning the products were inadvertently packaged together during bottling at a third 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 |
Image: FDA
Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues, according to a Food and Drug Administration press release. Sildenafil may interact with nitrates which are found in some prescription drugs taken by consumers with diabetes, high blood pressure or heart disease. Sildenafil, the active ingredient in Viagra, can interact with some medications such as nitroglycerin, lowering blood pressure to dangerous levels.
Taking trazodone may result in somnolence/sedation, dizziness, constipation and blurred vision, according to the FDA. 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 the recall.
Sildenafil is a PDE-5 inhibitor and is used for the treatment of erectile dysfunction. It 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 nationwide.
AvKARE has notified its distributors and customers and is arranging for return of all recalled products. Distributors should contact customer service by phone at 1-855-361-3993 or by email at customerservice@avkare.com.
Consumers can contact AvKARE by phone at 1-855-361-3993 Monday through Friday from 8 a.m. to 4 p.m. central standard time. 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 FDA said.
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
- 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
