FDAFDA · Food and drugs·Recall number D-458-2014
0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Published January 22, 2014 · Recall initiated: October 19, 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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Distributor
- Hospitals, clinics, physicians, and patients in the Michigan area only.
- Lot
- All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@8, 09302013@2, 10152013@6; b) Topical 09252013@9, 09302013@5, 10152013@8
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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