Class II · Moderate risk
Estrone 5mg/mL Oil Injection
Lack of sterility assurance.
Estrone 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
Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Affected NDCs
58597-8049-01
58597-8049-03
58597-8049-04
Compare with the code on your package — it is the most precise check available.
Drug: Estrone
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8049-3
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0491-2018 · 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 Estrone recalls
See all
Class II · Moderate risk
Estrone USP
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estrone
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Estrone
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk
Estrone Micronized
cGMP Deviations; lack of quality assurance.
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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