Drug product
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
D-0167-2021
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 86940
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38715 bottles
- Official record key
drug-enforcement:D-0167-2021
Official wording
Reason: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Code information: Lot: 36884 Exp. 03/2022
Distribution pattern: Nationwide within the U.S.
Derived failure modes
-
Unknown
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.