Class II · Moderate risk
Sildenafil Citrate USP
CGMP Deviations:Noted during FDA inspection
Sildenafil Citrate USP for prescription compounding
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Affected NDCs
58597-8088-02
58597-8088-04
58597-8088-05
58597-8088-06
58597-8088-07
58597-8088-08
Compare with the code on your package — it is the most precise check available.
Drug: Sildenafil
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8088-2
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0519-2018 · 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 Tablets USP 100 mg
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
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.
Other recalls by American Pharmaceutical Ingredients LLC
All 2018 recalls
Class II · Moderate risk
Sermorelin Acetate
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Oxytocin USP
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Fluticasone propionate USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Cyanocobalamin USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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