Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
TraZODONE Hydrochloride Tablets USP 100 mg
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
Affected NDC
42291-0834-10
Compare with the code on your package — it is the most precise check available.
Drug: Trazodone
- Recalling firm
- AVKARE Inc.
- NDC code
- 42291-834-10
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0168-2021 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Trazodone recalls
See all
Class II · Moderate risk
Trazodone Hydrochloride
Presence of Foreign Tablets/Capsules
Class III · Low risk
traZODONE Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class II · Moderate risk
Trazodone Hydrochloride Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Trazodone HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by AVKARE Inc.
All 2020 recalls
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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