BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream)...
FDA Drug Recall #D-0208-2016 — Class II — March 10, 2015
Recall Summary
| Recall Number | D-0208-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 10, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | the Compounder |
| Location | Aurora, IL |
| Product Type | Drugs |
| Quantity | 1(1mL) syringe, 56 (3mL) syringes |
Product Description
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Distribution Pattern
Nationwide
Lot / Code Information
a) Lot # 12292014:90@21, Exp 6/27/2015; b) Lot # 02032015:55@13, Exp 8/2/2015
Other Recalls from the Compounder
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0204-2016 | Class II | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Es... | Mar 10, 2015 |
| D-0202-2016 | Class II | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/E... | Mar 10, 2015 |
| D-0212-2016 | Class II | BIEST TD 91/9 (Estriol USP Micronized (E3)/Estr... | Mar 10, 2015 |
| D-0227-2016 | Class II | TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estr... | Mar 10, 2015 |
| D-0225-2016 | Class II | ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yello... | Mar 10, 2015 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.