FDAFDA · Food and drugs·Recall number D-0417-2018
Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91
Published February 21, 2018 · Recall initiated: February 5, 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
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AZELASTINE HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Nationwide
- Lot
- JKR7706A December 2018 JKR7705A November 2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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