Apotex Recalls Azelastine Hydrochloride Nasal Solution Due to CGMP Deviations
Apotex Corp. is recalling Azelastine Hydrochloride Nasal Solution because tubing used for filling may interact with the nasal formulation.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly classifies the recall as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Apotex Corp. is recalling Azelastine Hydrochloride Nasal Solution, 0.1%, 137 mcg/spray, 30 mL bottles (NDC 60505-0833-5). The recall involves 963,407 bottles distributed nationwide and in Puerto Rico. Affected lot numbers include JK9130, JM0925 (Exp 05/12), JN6514 (Exp 07/12), JN1125, JN1127 (Exp 08/12), and JR5780, JR5782 (Exp 12/12).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the tubing used for filling the product may interact with the nasal formulation. This is classified as an FDA Class III recall, indicating that the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. No specific instructions for disposal or replacement are provided in the source text.
The recalled product
- Product
- AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
- Brand
- AZELASTINE HYDROCHLORIDE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Nasal Spray
- Affected units
- 963,407
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot #: JK9130
- JM0925
- Exp 05/12
- JN6514
- Exp 07/12
- JN1125
- JN1127
- Exp 08/12
- JR5780
- JR5782
- Exp 12/12.
Distribution
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