FDA Recall Dymista

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Dymista with NDC 0037-0245 was initiated on 02-01-2019 as a Class II recall due to defective container: potential for broken glass in the neck area of the glass bottles. The latest recall number for this product is D-0424-2019 and the recall is currently terminated as of 09-09-2019 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0424-201902-01-201902-13-2019Class II10,390 bottlesDymista (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.Terminated
D-1075-201807-25-201808-15-2018Class II20,780 bottlesDymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.