Recalls / Class II
Class IID-1411-2015
Product
Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
- Affected lot / code info
- 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
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
- 61 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-1411-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.