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[Mindy D]

AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Summary

Company Announcement Date: December 09, 2020 FDA Publish Date: December 09, 2020 Product Type: Drugs Reason for Announcement:

Due to product mix-up

Company Name: AvKare Brand Name:

AvKare

Product Description:

Sildenafil 100 mg tablets and Trazodone 100mg tablets

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Company Announcement

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.  

ProductLotExpiration dateBottle countNDC 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 customerservice@avkare.com 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
• 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.

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Company Contact Information

Consumers: Customer Service at AvKARE 1-855-361-3993 customerservice@avkare.com

Media: Clifton Stanfill 931-908-2192

[Mindy D]

[Carmie]

Whoa, that is scary. 

I hope no one comes to any harm from this.

[Mindy D]

Trazodone is widely used for insomnia besides the treatment of depression.

[goldensrbest]

I take this at night.The shape of the pill should make one  aware something is wrong.

[BlueFinch]

That really instills pharmaceutical confidence, doesn't it. 

[Cakers3]

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@goldensrbest wrote:

I take this at night.The shape of the pill should make one  aware something is wrong.

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@goldensrbest   I agree but some people may be taking these for the first time.

Although most pharmacies label the containers with a description of the pills inside, some may not be aware to check this out.

[Mindy D]

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@Cakers3 wrote:

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@goldensrbest wrote:

I take this at night.The shape of the pill should make one  aware something is wrong.

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@goldensrbest   I agree but some people may be taking these for the first time.

Although most pharmacies label the containers with a description of the pills inside, some may not be aware to check this out.

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@Cakers3 @The pharmacies should be getting this information now, but a pharmacy could miss this and any employee filling the RX bottle could easily take, what he thinks are Trazodone pills and put the pills throughh the counter and into the RX bottle. Hopefully, the employees will read the recall as soon as it shows up. This could happen with 24 hour pharmacies open tonight. The recall should show up on their screens when they go to input the scripts. 

[Cakers3]

@Mindy D   I meant some customers may not check out the description, not the pharmacy.

Either way, the pharmacies (hopefully) have been notified and will have records of anyone who has recently filled either med.

[skatting44]

 What a  mix up !   Two meds for 2 different conditions !

Pays, to question and check everything