Recalls / Class II
Class IID-961-2013
Product
GLUTATHIONE 200 MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Affected lot / code info
- 03192013@30, 02202013@6, 04042013@2, 04302013@20, 04252013@19 06202013@35, 06212013@17
Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recalling firm
- Firm
- Beacon Hill Medical Pharmacy, P.C.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 18161 W 13 Mile Rd, Suite A1, Southfield, Michigan 48076-1113
Distribution
- Quantity
- N/A
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2013-07-26
- FDA classified
- 2013-09-10
- Posted by FDA
- 2013-09-18
- Terminated
- 2014-07-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-961-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.