Why it was recalled
Presence of foreign substance: Potential for 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, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23
Lot numbers, UPCs & expiration codes
Lot #: GA70246, GA70254, Exp 02/2019
Where it was sold
U.S. Nationwide
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-1075-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 25, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 20,780 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1075-2018, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 77850
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: GA70246, GA70254, Exp 02/2019
- Postal code
- 26505-2730
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1075-2018
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 20,780 bottles
- Termination date
- Aug 15, 2019
- Reason for recall
- Presence of foreign substance: Potential for 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, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jul 25, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2018