Why it was recalled
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Product description
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Lot numbers, UPCs & expiration codes
Lot: 36884 Exp. 03/2022
Where it was sold
Nationwide within the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0167-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 7, 2020
- FDA report date
- Dec 23, 2020
- Quantity
- 38715 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0167-2021, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 86940
- Address
- 615 N 1st St
- Code information
- Lot: 36884 Exp. 03/2022
- Postal code
- 38478-2403
- Report date
- Dec 23, 2020
- Product type
- Drugs
- Recall number
- D-0167-2021
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 38715 bottles
- Termination date
- Oct 16, 2023
- Reason for recall
- Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
- Distribution pattern
- Nationwide within the U.S.
- Recall initiation date
- Dec 7, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2020