Why it was recalled
Defective Container: Potential for broken glass in the neck area of the glass 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.
Lot numbers, UPCs & expiration codes
Lot: GA70535, Exp. April 2019
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0424-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 1, 2019
- FDA report date
- Feb 13, 2019
- Quantity
- 10,390 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0424-2019, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 81980
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot: GA70535, Exp. April 2019
- Postal code
- 26505-2730
- Report date
- Feb 13, 2019
- Product type
- Drugs
- Recall number
- D-0424-2019
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 10,390 bottles
- Termination date
- Sep 9, 2019
- Reason for recall
- Defective Container: Potential for broken glass in the neck area of the glass bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2019