RecallRadar

FDA Drug recall D-1415-2015

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

On 2015-09-09 the FDA classified a Class II recall of Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA by South Coast Specialty Compounding, citing penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1415-2015
ClassificationClass II
Statusterminated
Initiated2015-04-23
Published2015-09-09
Last updated2026-09-13 11:51 UTC
CompanySouth Coast Specialty Compounding
DistributionUS

Product

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

Reason

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

Identifiers

code_info
Lot #: 01052015@12 01132015@2 01132015@36 01132015@37 01152015@4 01162015@66 01202015@34 02112015@11 02112015@…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1415-2015%22

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