Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
ESTRIOL (weight/volume)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Drug: Estriol
- Recalling firm
- the Compounder
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0224-2016 · 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 Estriol recalls
See all
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Estriol USP41 Micro 25 Grams
cGMP Deviations
Class II · Moderate risk
Estriol 8 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol 6 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Other recalls by the Compounder
All 2015 recalls
Class II · Moderate risk
Triest 80/10/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Triest 80/10/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Triest 70/20/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Estriol 5 Estradiol
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
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