Recalls / Class III
Class IIID-1667-2012
Product
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.
- Brand name
- Azelastine Hydrochloride
- Generic name
- Azelastine Hydrochloride
- Active ingredient
- Azelastine Hydrochloride
- Route
- Nasal
- NDC
- 60505-0833
- FDA application
- ANDA077954
- Affected lot / code info
- Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
Why it was recalled
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 963,407 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2011-06-15
- FDA classified
- 2012-08-29
- Posted by FDA
- 2012-09-05
- Terminated
- 2012-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1667-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.