Recalls / Class II
Class IID-1408-2015
Product
Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
- Affected lot / code info
- All Lots, Exp 09/15
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
- 2,370 capsules (40 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-1408-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.