D-1075-2018 Class II Terminated
FDA drug recall D-1075-2018 was initiated by Mylan Pharmaceuticals Inc. on Jul 25, 2018 and is designated Class II. Reason for recall: Presence of foreign substance: Potential for glass in the neck area of the glass bottles. The recall status is terminated (terminated Aug 15, 2019). Affected quantity: 20,780 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 15, 2018
- Initiation Date
- Jul 25, 2018
- Termination Date
- Aug 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,780 bottles
Product description
Dymista (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 0037-0245-23
Reason for recall
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Distribution pattern
U.S. Nationwide
Code information
Lot #: GA70246, GA70254, Exp 02/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1075-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026