TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

FDA recall notice · announced December 23, 2020 · Avkare

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

Reason for recall

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

Notes

Distribution: Nationwide within the U.S.
Lot/code information: Lot: 36783 Exp. 06/2022
Quantity: 14368 bottles
Status: Terminated
Products in this recall event:
- Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01. (D-0167-2021)
- TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10 (D-0168-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.