FDAFDA · Food and drugs·Recall number D-0935-2018
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65
Published July 25, 2018 · Recall initiated: June 12, 2018
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: Potential leakage of bags.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Distributor
- Nationwide in the USA
- Lot
- Lot # 5/16/18 1207 22265S, BUD 8/14/2018.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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