Why it was recalled
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Product description
HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Lot numbers, UPCs & expiration codes
Lot # / Beyond Use Date: 05192014@15 / BUD 07/18/14; 04142014@39 / BUD 6-13-14; 04182014@4 / BUD 6-17-14; 04162014@12 / BUD 06/15/14; 05092014@34 / BUD 07/08/14; 04162014@35 / BUD 06/15/14; 05232014@33 / BUD 07/22/14; 05022014@36 / BUD 7/1/14; 04292014@13 / BUD 06/28/14; 04282014@43 / BUD 06/27/14; 05212014@5 / BUD 07/20/14; 04292014@13 / BUD 06/28/14; 05062014@42 / BUD 07/05/14; 05022014@36 / BUD 07/01/14; 05062014@45 / BUD 07/05/14; 05082014@2 / BUD 07/07/14, 05152014@36 / BUD 7/14/14; 05212014@5 / BUD 07/20/14; 05082014@2 / BUD 07/07/14; 05132014@37 / BUD 07/12/14; 05082014@2 / BUD 07/07/14; 05132014@38 / BUD 07/12/14; 04242014@14 / BUD 6-23-14; 04162014@12 / BUD 6-15-14; 04212014@27 / BUD 6-20-14; 04292014@13 / BUD 6-28-14; 05092014@34 / BUD 7-8-14; 05212014@5 / BUD 7-20-14; 05272014@58 / BUD 7-26-14; 05222014@27 / BUD 07/21/14
Where it was sold
WI only
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-1418-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 30, 2014
- FDA report date
- Jul 9, 2014
- Quantity
- 184 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Brookfield Prescription Center Inc. dba MD Custom Rx
Original FDA data
Every field from FDA enforcement report D-1418-2014, exactly as published.
Show all FDA fields
- City
- Brookfield
- State
- WI
- Status
- Terminated
- Country
- United States
- Event ID
- 68616
- Address
- 19035 W. Capitol Dr
- Address (line 2)
- Suite 105
- Code information
- Lot # / Beyond Use Date: 05192014@15 / BUD 07/18/14; 04142014@39 / BUD 6-13-14; 04182014@4 / BUD 6-17-14; 04162014@12 / BUD 06/15/14; 05092014@34 / BUD 07/08/14; 04162014@35 / BUD 06/15/14; 05232014@33 / BUD 07/22/14; 05022014@36 / BUD 7/1/14; 04292014@13 / BUD 06/28/14; 04282014@43 / BUD 06/27/14; 05212014@5 / BUD 07/20/14; 04292014@13 / BUD 06/28/14; 05062014@42 / BUD 07/05/14; 05022014@36 / BUD 07/01/14; 05062014@45 / BUD 07/05/14; 05082014@2 / BUD 07/07/14, 05152014@36 / BUD 7/14/14; 05212014@5 / BUD 07/20/14; 05082014@2 / BUD 07/07/14; 05132014@37 / BUD 07/12/14; 05082014@2 / BUD 07/07/14; 05132014@38 / BUD 07/12/14; 04242014@14 / BUD 6-23-14; 04162014@12 / BUD 6-15-14; 04212014@27 / BUD 6-20-14; 04292014@13 / BUD 6-28-14; 05092014@34 / BUD 7-8-14; 05212014@5 / BUD 7-20-14; 05272014@58 / BUD 7-26-14; 05222014@27 / BUD 07/21/14
- Postal code
- 53045
- Report date
- Jul 9, 2014
- Product type
- Drugs
- Recall number
- D-1418-2014
- Classification
- Class II
- Recalling firm
- Brookfield Prescription Center Inc. dba MD Custom Rx
- Product quantity
- 184 mL
- Termination date
- May 22, 2015
- Reason for recall
- Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
- Distribution pattern
- WI only
- Recall initiation date
- May 30, 2014
- Initial firm notification
- Telephone
- Center classification date
- Jul 3, 2014