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Recall Observatory FDA recall evidence

Drug product

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

D-1411-2015

April 23, 2015

Class II

Product summary

Firm
South Coast Specialty Compounding, Inc.
Event
Event 71078
Status
Terminated
Classification
Class II
Quantity
61 prescriptions
Official record key
drug-enforcement:D-1411-2015

Official wording

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

Code information: Lot #: 01022015@46 01022015@50 01052015@23 01072015@38 01072015@39 01082015@36 01082015@9 01092015@26 01122015@40 01142015@11 01142015@16 01152015@44 01162015@31 01162015@38 01192015@35 01222015@17 01222015@19 01272015@38 02022015@30 02022015@30 02062015@35 02112015@30 02112015@30 02202015@3 02202015@3 10272014@39 10312014@14 10312014@36 11042014@29 11042014@39 11042014@52 11072014@38 11072014@38 11072014@38 11072014@38 11072014@7 11112014@4 11132014@29 11142014@17 11182014@45 11192014@31 11202014@49 11242014@44 11252014@59 11252014@59 11252014@59 11252014@59 11252014@59 11252014@59 11282014@14 12012014@21 12012014@22 12022014@20 12022014@38 12092014@5 12092014@56 12092014@66 12112014@22 12152014@28 12152014@44 12152014@56 12162014@30 12172014@23 12172014@36 12222014@6 12232014@57 12242014@15 12262014@11 12262014@11 12262014@24 12312014@23 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.