Class II · Moderate risk
Sildenafil Citrate USP
CGMP Deviations:Noted during FDA inspection
Sildenafil Tablets USP 100 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Affected NDC
42291-0748-01
Compare with the code on your package — it is the most precise check available.
Drug: Sildenafil
- Recalling firm
- AVKARE Inc.
- NDC code
- 42291-748-01
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0167-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Sildenafil recalls
See all
Class II · Moderate risk
Sildenafil Citrate USP
CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk
Sildenafil 50 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Sildenafil 80 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Sildenafil 200 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
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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