Why it was recalled
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Product description
Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Lot numbers, UPCs & expiration codes
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
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-1411-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 23, 2015
- FDA report date
- Sep 9, 2015
- Quantity
- 61 prescriptions
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- South Coast Specialty Compounding, Inc.
Original FDA data
Every field from FDA enforcement report D-1411-2015, 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@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
- Postal code
- 92618-4286
- Report date
- Sep 9, 2015
- Product type
- Drugs
- Recall number
- D-1411-2015
- Classification
- Class II
- Recalling firm
- South Coast Specialty Compounding, Inc.
- Product quantity
- 61 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
- Estriol,Estradiol 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