FDAFDA · Food and drugs·Recall number D-966-2013
H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Published September 18, 2013 · Recall initiated: July 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Distributor
- USA nationwide
- Lot
- 01242013@23, 03132013@20, 04232013@21, 06112013@31, 03282013@24, 02042013@9, 03092013@6, 04122013@10, 04232013@24, 05232013@8, 06192013@26, 07102013@18, 07132013@6, 01072013@3, 02192013@10, 04172013@23, 06192013@28, 07102013@15, 07132013@8, 03232013@4, 03282013@22, 01032013@5, 01182013@24, 02052013@8, 03062013@5, 04122013@4, 04232013@26, 05132013@15, 05232013@5, 06182013@31, 06212013@12, 07132013@4, 03282013@27, 01032013@3, 01242013@16, 02192013@7, 03062013@2, 04122013@8, 04232013@29, 05232013@10, 06112013@28, 06182013@36, and 06242013@21.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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