Recalls / Class II
Class IID-1413-2015
Product
Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
- Affected lot / code info
- 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
Why it was recalled
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recalling firm
- Firm
- South Coast Specialty Compounding, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9257 Research Dr, N/A, Irvine, California 92618-4286
Distribution
- Quantity
- 24 prescriptions
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2015-04-23
- FDA classified
- 2015-09-02
- Posted by FDA
- 2015-09-09
- Terminated
- 2016-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1413-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.