Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Drug: Estradiol
- Recalling firm
- The Compounding Pharmacy of America
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1478-2015 · 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 Estradiol recalls
See all
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Other recalls by The Compounding Pharmacy of America
All 2015 recalls
Class I · High risk
Hcg 5
Non-Sterility
Class II · Moderate risk
Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-50/PGE 1 0.14/0.08 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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