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Recall Observatory FDA recall evidence

Drug product

HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892

D-0600-2018

January 12, 2018

Class I

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 79168
Status
Terminated
Classification
Class I
Quantity
5 vials
Official record key
drug-enforcement:D-0600-2018

Official wording

Reason: Non-Sterility

Code information: Lot: 01052018@46 Use By: 2/9/2018

Distribution pattern: TN, SC

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility