FDAFDA · Food and drugs·Recall number D-1398-2019
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
Published June 19, 2019 · Recall initiated: May 21, 2019
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
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- AMIKACIN SULFATE
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Distributor
- Nationwide in the USA
- UPC
- 0323155290325
- Lot
- Lot: VEAC025, EXP 10-2019
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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