Recalls / Class I
Class ID-0168-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
- Affected lot / code info
- Lot: 36783 Exp. 06/2022
Why it was recalled
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 14368 bottles
- Distribution pattern
- Nationwide within the U.S.
Timeline
- Recall initiated
- 2020-12-07
- FDA classified
- 2020-12-16
- Posted by FDA
- 2020-12-23
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0168-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.