Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
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 Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Reason cGMP Deviations
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.