D-0424-2019 Class II Terminated
FDA drug recall D-0424-2019 was initiated by Mylan Pharmaceuticals Inc. on Feb 1, 2019 and is designated Class II. Reason for recall: Defective Container: Potential for broken glass in the neck area of the glass bottles. The recall status is terminated (terminated Sep 9, 2019). Affected quantity: 10,390 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 13, 2019
- Initiation Date
- Feb 1, 2019
- Termination Date
- Sep 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,390 bottles
Product description
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.
Reason for recall
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Distribution pattern
Nationwide in the USA.
Code information
Lot: GA70535, Exp. April 2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0424-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026