Recalls / Class II
Class IID-1412-2015
Product
Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
- Affected lot / code info
- Lot #: 01022015@18 01022015@26 01052015@34 01052015@39 01052015@57 01062015@52 01082015@29 01082015@57 01082015@60 01092015@23 01092015@26 01092015@27 01092015@28 01092015@29 01092015@31 01092015@43 01092015@44 01092015@45 01122015@42 01122015@63 01132015@35 01132015@36 01132015@37 01132015@44 01132015@52 01142015@50 01152015@20 01152015@31 01162015@14 01162015@5 01162015@60 01162015@8 01192015@28 01192015@32 01192015@53 01202015@19 01202015@29 01202015@33 01202015@34 01202015@36 01212015@38 01232015@13 01232015@19 01232015@30 01232015@48 01262015@26 01262015@32 01262015@34 01262015@36 01262015@42 01272015@2 01272015@33 01272015@4 01282015@5 02032015@41 02032015@41 02032015@41 02162015@62 02162015@62 02182015@47 02242015@26 03032015@22 03032015@22 03032015@22 03042015@41 03062015@31 03062015@61 03092015@55 10272014@19 10272014@29 10272014@43 10282014@11 10282014@49 10292014@15 10292014@31 10292014@32 10312014@13 10312014@27 11032014@34 11032014@38 11032014@64 11032014@75 11042014@27 11042014@32 11052014@25 11052014@4 11052014@43 11052014@44 11052014@46 11052014@50 11062014@3 11072014@15 11072014@20 11072014@35 11102014@34 11102014@52 11112014@1 11112014@51 11122014@1 11122014@3 11122014@37 11122014@44 11122014@45 11122014@53 11122014@55 11132014@58 11142014@35 11142014@36 11172014@10 11172014@33 11182014@15 11182014@3 11182014@6 11192014@8 11202014@36 11202014@43 11202014@50 11202014@53 11202014@9 11212014@17 11212014@27 11242014@26 11242014@28 11242014@58 11252014@26 11252014@33 11252014@37 11252014@4 11252014@50 11262014@61 11282014@2 11282014@31 11282014@35 12012014@20 12012014@22 12022014@9 12032014@19 12032014@39 12042014@3 12052014@23 12052014@31 12052014@33 12052014@9 12082014@22 12082014@31 12082014@46 12092014@72 12102014@2 12102014@4 12102014@56 12112014@47 12112014@50 12122014@6 12152014@23 12152014@29 12152014@45 12152014@46 12152014@53 12152014@67 12162014@24 12162014@29 12162014@4 12162014@44 12172014@10 12172014@30 12172014@37 12182014@14 12182014@2 12182014@5 12192014@11 12192014@17 12192014@29 12222014@36 12222014@47 12232014@26 12232014@29 12232014@31 12232014@32 12232014@41 12232014@48 12232014@5 12232014@51 12232014@56 12242014@18 12242014@26 12262014@19 12262014@4 12292014@26 12292014@56 12302014@21 12302014@46 12312014@14 12312014@2 12312014@20 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
- 211 presciptions
- 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-1412-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.