FDAFDA · Food and drugs·Recall number D-0093-2018
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
Published November 29, 2017 · Recall initiated: November 6, 2017
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
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DEXAMETHASONE SODIUM PHOSPHATE
- Manufacturer
- West-Ward Pharmaceuticals Corp.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot #: 106390, 106393, 106395, Exp 10/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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