Why it was recalled
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Product description
HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 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: 04302014@21 / BUD 06/29/14
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-1421-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 30, 2014
- FDA report date
- Jul 9, 2014
- Quantity
- 8 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-1421-2014, 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: 04302014@21 / BUD 06/29/14
- Postal code
- 53045
- Report date
- Jul 9, 2014
- Product type
- Drugs
- Recall number
- D-1421-2014
- Classification
- Class II
- Recalling firm
- Brookfield Prescription Center Inc. dba MD Custom Rx
- Product quantity
- 8 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) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 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