Safety Alerts & Recalls

What does this mean?

This recall for Ipratropium Bromide Nasal Solution, from Apotex, Inc. was issued at a warehouse/pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. If you use Ipratropium Bromide Nasal Solution and are concerned, you should consult with your physician or pharmacist.

Apotex Recalls Two Lots of Ipratropium Nasal Solution

Apotex, Inc. is recalling two lots of Ipratropium Bromide Nasal Solution due to possible contamination with metal fragments. The following lot numbers and expiration dates (Exp) are being recalled: 1) Ipratropium Bromide Nasal Solution, 0.03%, 30 mL bottle - Lot: JK0843, Exp 01/12

2) Ipratropium Bromide Nasal Solution, 0.06%, 15 mL bottle - Lot: JK0840, Exp 12/11

Ipratropium Bromide Nasal Solution is used in the treatment of a runny nose due to the common cold or allergies. Ipratropium is also sold under the brand name Atrovent. Other formulations of ipratropium are used to treat lung conditions, including chronic obstructive pulmonary disease (COPD). This recall alert only applies to the two lots of the generic Ipratropium Bromide Nasal Solution made by Apotex. No other ipratropium products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2010-04-20
Last Updated: 2010-04-20

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