Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA

FDA recall notice · announced September 9, 2015 · South Coast Specialty Compounding

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA

Reason for recall

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Notes

Distribution: Nationwide.
Lot/code information: 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
Quantity: 24 suppositories (24 prescriptions)
Status: Terminated
Products in this recall event:
- Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1409-2015)
- Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1337-2015)
- Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1414-2015)
- Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation (D-1339-2015)
- Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA (D-1341-2015)
- Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA (D-1342-2015)
- Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1412-2015)
- Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1338-2015)
- Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1340-2015)
- Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1411-2015)
- Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1410-2015)
- Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA (D-1407-2015)
- Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1408-2015)
- Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1413-2015)
- Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA (D-1415-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.