Why it was recalled
Presence of foreign substance: glass particles
Product description
Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1
Lot numbers, UPCs & expiration codes
Lot: NJ4501 Exp. 07/2020
Where it was sold
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-0841-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 31, 2018
- FDA report date
- Jun 13, 2018
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0841-2018, exactly as published.
Show all FDA fields
- City
- North York
- Status
- Terminated
- Country
- Canada
- Event ID
- 80202
- Address
- 150 Signet Dr
- Code information
- Lot: NJ4501 Exp. 07/2020
- Report date
- Jun 13, 2018
- Product type
- Drugs
- Recall number
- D-0841-2018
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- Unknown
- Termination date
- Sep 28, 2022
- Reason for recall
- Presence of foreign substance: glass particles
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1
- Distribution pattern
- Nationwide
- Recall initiation date
- May 31, 2018
- Initial firm notification
- Press Release
- Center classification date
- Jun 6, 2018