Reported Sep 5, 2012 · Terminated
Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc.,…
Apotex Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253
Is this the product you have?
Azelastine HCl Nasal Solution0.1 %137 mcg/spray30 mL bottle (200 Metered Sprays)Rx only
- Mfg byApotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5
- Lot codes and dates
Lot #: JK9130JM0925Exp 05/12JN6514Exp 07/12JN1125JN1127Exp 08/12JR5780JR5782Exp 12/12
- Amount recalled
- 963,407 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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