CLASS II Drug recall · Reported 9 Sep 2015 · FDA Enforcement Report
Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository recalled
South Coast Specialty Compounding is recalling Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, distributed nationwide in the US. The recall was initiated on 23 Apr 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1415-2015
- FDA event ID
- 71078
- Recalling firm
- South Coast Specialty Compounding, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Apr 2015
- FDA classified
- 2 Sep 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 23 Apr 2015 | Recall initiated by company | |
| 2 Sep 2015 | Classified by FDA | +132 days |
| 9 Sep 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Product as listed by the FDA
Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Which lots are affected?
Lot #: 01052015@12 01132015@2 01132015@36 01132015@37 01152015@4 01162015@66 01202015@34 02112015@11 02112015@11 02252015@34 10312014@13 11042014@42 11052014@46 11072014@21 11122014@43 11122014@45 11182014@15 11192014@41 11242014@29 11262014@14 12022014@13 12102014@4 12192014@40 12222014@18 Exp. 07/15
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 71078More recalls from South Coast Specialty Compounding
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol cream recalled by South Coast Specialty | South Coast Specialty Compounding | Other | Nationwide |
| Drug | CLASS II | Estradiol, Estriol, Progesterone capsules recalled | South Coast Specialty Compounding | Other | Nationwide |
| Drug | CLASS II | Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone recalled | South Coast Specialty Compounding | Other | Nationwide |
| Drug | CLASS II | Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops recalled | South Coast Specialty Compounding | Other | Nationwide |
| Drug | CLASS II | Estriol,Estradiol cream recalled by South Coast Specialty | South Coast Specialty Compounding | Other | Nationwide |