Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP-SS OIL- 5MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Reason Defective Container; packets were found to be either empty or partially full.
Reason Presence of Foreign substance - potential presence of metal particulate matter
Reason Presence of Foreign substance - potential presence of metal particulate matter
Reason Presence of Foreign substance - potential presence of metal particulate matter
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