Why it was recalled
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Product description
Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.
Lot numbers, UPCs & expiration codes
Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
Where it was sold
Nationwide and Puerto Rico
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-1667-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 15, 2011
- FDA report date
- Sep 5, 2012
- Quantity
- 963,407 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-1667-2012, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62930
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
- Postal code
- 33326-3253
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1667-2012
- Classification
- Class III
- Recalling firm
- Apotex Corp.
- Product quantity
- 963,407 bottles
- Termination date
- Sep 18, 2012
- Reason for recall
- CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jun 15, 2011
- Initial firm notification
- Letter
- Center classification date
- Aug 29, 2012