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Recall Observatory FDA recall evidence

Drug product

Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA

D-1413-2015

April 23, 2015

Class II

Product summary

Firm
South Coast Specialty Compounding, Inc.
Event
Event 71078
Status
Terminated
Classification
Class II
Quantity
24 prescriptions
Official record key
drug-enforcement:D-1413-2015

Official wording

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

Code information: Lot # 01022015@21 01022015@41 01052015@61 01122015@36 01162015@62 01162015@64 01202015@51 01212015@28 10272014@18 11032014@50 11132014@26 11142014@25 11242014@46 11242014@9 12032014@20 12052014@18 12122014@21 12152014@35 12152014@57 12162014@32 12172014@12 12182014@6 12222014@51 12302014@22 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.