Class II · Moderate risk
Estrone USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Estrone 5mg/mL Oil Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drug: Estrone
- Recalling firm
- Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1195-2019 · 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 Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
All 2019 recalls
Class II · Moderate risk
Prostaglandin Tri-Mix 30:30:1 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 20:25:1 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection
Lack of sterility assurance.
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