Status
Terminated
Drug Enforcement D-1667-2012
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Classification
Class III
Report Date
September 5, 2012
Termination Date
September 18, 2012
Product Information
- 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.
- Product quantity
- 963,407 bottles
- Reason for recall
- CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Apotex Corp.
- Address
-
2400 N Commerce Pkwy Ste 400, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1667-2012
- Event ID
- 62930
- Recall initiation date
- June 15, 2011
- Center classification date
- August 29, 2012
- Code info
- Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
- More code info
- —