Dymista — Class II drug recall D-0424-2019
Terminated recall by Mylan Pharmaceuticals Inc., reported 2019-02-13, distributed nationwide. Defective Container: Potential for broken glass in the neck area of the glass bottles.
| Recall number | D-0424-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2019-02-01 |
| Classified | 2019-02-04 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2019-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 10,390 bottles |
| Reason classes | foreign material, packaging |
| NDC | 00037-0245, 00037-0245-23 |
| Lot numbers | GA70535 |
| Expiration dates | 2019-04-20 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0424-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.