KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Reported: September 18, 2013 Initiated: July 26, 2013 #D-971-2013
Product Description
KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Reason for Recall
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Details
- Recalling Firm
- Beacon Hill Medical Pharmacy, P.C.
- Units Affected
- N/A
- Distribution
- USA nationwide
- Location
- Southfield, MI
Frequently Asked Questions
What product was recalled? ▼
KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI. Recalled by Beacon Hill Medical Pharmacy, P.C.. Units affected: N/A.
Why was this product recalled? ▼
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 18, 2013. Severity: Moderate. Recall number: D-971-2013.
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