Drug recall: Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding…
Class II FDA enforcement event 71078. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
South Coast Specialty Compounding, Inc. started this drug recall on 23 Apr 2015. The firm address in the FDA record is in Irvine, CA. FDA put the recall in Class II. FDA event 71078 has 15 product records. The first FDA enforcement report date is 9 Sep 2015. The record gives the status Terminated, with the termination date 31 May 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide.
Recalling firm
South Coast Specialty Compounding, Inc., Irvine, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
15 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1337-2015 | Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA | ALL LOTS | Class II | Terminated | 9 Sep 2015 |
| D-1338-2015 | Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA | 2,355 capsules ( 26 presciptions) | Class II | Terminated | 9 Sep 2015 |
| D-1339-2015 | Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation | 40 capsules ( 1 prescription) | Class II | Terminated | 9 Sep 2015 |
| D-1340-2015 | Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA | 172 vials ( 100 prescriptions) | Class II | Terminated | 9 Sep 2015 |
| D-1341-2015 | Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA | 337 vials (112 prescriptions) | Class II | Terminated | 9 Sep 2015 |
| D-1342-2015 | Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA | 335 vials (114 prescriptions) | Class II | Terminated | 9 Sep 2015 |
| D-1407-2015 | Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA | 2,380 capsules ( 39 prescriptions) | Class II | Terminated | 9 Sep 2015 |
| D-1408-2015 | Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA | 2,370 capsules (40 prescriptions) | Class II | Terminated | 9 Sep 2015 |
| D-1409-2015 | Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA | 540 capsules (11 prescriptions) | Class II | Terminated | 9 Sep 2015 |
| D-1410-2015 | Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA | 5 prescriptions | Class II | Terminated | 9 Sep 2015 |
| D-1411-2015 | Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA | 61 prescriptions | Class II | Terminated | 9 Sep 2015 |
| D-1412-2015 | Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA | 211 presciptions | Class II | Terminated | 9 Sep 2015 |
| D-1413-2015 | Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA | 24 prescriptions | Class II | Terminated | 9 Sep 2015 |
| D-1414-2015 | Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA | 36 prescriptions | Class II | Terminated | 9 Sep 2015 |
| D-1415-2015 | Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA | 24 suppositories (24 prescriptions) | Class II | Terminated | 9 Sep 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2015
- 292
- Share of these events in Class II
- 52%
- Product records in this event
- 15Median of the firm: 15
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Aug 2013 | Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvi | Drug | Class II | 3 |
Official channels
- FDA enforcement report D-1337-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 71078. https://recallregister.com/fda/ii/71078/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide.
- What quantity of product is in FDA event 71078?
- The event has 15 product records. The first record gives this quantity:
ALL LOTS
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2015 have the same class?
- 52% of the 292 drug events that started in 2015 are in Class II.