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Recall Observatory FDA recall evidence

Drug product

Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA

D-1410-2015

April 23, 2015

Class II

Product summary

Firm
South Coast Specialty Compounding, Inc.
Event
Event 71078
Status
Terminated
Classification
Class II
Quantity
5 prescriptions
Official record key
drug-enforcement:D-1410-2015

Official wording

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

Code information: Lot # 01152015@20,03032015@22, 03032015@22, 03092015@55,12052014@20; Exp 07/15

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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