Recalls / Class II
Class IID-1414-2015
Product
Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
- Affected lot / code info
- Lot #: 01022015@18 01132015@36 01132015@44 01142015@39 01152015@20 01222015@36 01232015@30 01272015@2 01282015@5 03102015@21 03122015@50 03122015@50 10312014@27 11052014@4 11062014@3 11072014@20 11102014@1 11112014@35 11122014@15 11122014@45 11132014@58 11142014@35 11252014@50 11282014@2 12032014@39 12082014@31 12102014@4 12152014@32 12162014@4 12172014@10 12192014@17 12192014@29 12232014@56 12242014@26 12262014@19 12312014@2 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
- 36 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-1414-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.