Why it was recalled
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Product description
Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1414-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 23, 2015
- FDA report date
- Sep 9, 2015
- Quantity
- 36 prescriptions
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- South Coast Specialty Compounding, Inc.
Original FDA data
Every field from FDA enforcement report D-1414-2015, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 71078
- Address
- 9257 Research Dr
- Code information
- 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
- Postal code
- 92618-4286
- Report date
- Sep 9, 2015
- Product type
- Drugs
- Recall number
- D-1414-2015
- Classification
- Class II
- Recalling firm
- South Coast Specialty Compounding, Inc.
- Product quantity
- 36 prescriptions
- Termination date
- May 31, 2016
- Reason for recall
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 23, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 2, 2015