D-1667-2012 Class III Terminated
FDA drug recall D-1667-2012 was initiated by Apotex Corp. on Jun 15, 2011 and is designated Class III. Reason for recall: CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. The recall status is terminated (terminated Sep 18, 2012). Affected quantity: 963,407 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 5, 2012
- Initiation Date
- Jun 15, 2011
- Termination Date
- Sep 18, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 963,407 bottles
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.
Reason for Recall
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1667-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026