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Recall Observatory FDA recall evidence

Drug product

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

D-1421-2014

May 30, 2014

Class II

Product summary

Firm
Brookfield Prescription Center Inc. dba MD Custom Rx
Event
Event 68616
Status
Terminated
Classification
Class II
Quantity
8 mL
Official record key
drug-enforcement:D-1421-2014

Official wording

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

Code information: Lot # / Beyond Use Date: 04302014@21 / BUD 06/29/14

Distribution pattern: WI only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.