Safety Alerts & Recalls

What does this mean?

At this time, there have been no reports of problems with these recalled lot numbers of Brompheniramine Tannate Suspension. However, since the recalled product has not been reviewed and approved by the FDA, you may wish to check your prescription to see if it is involved in the recall. Check your prescription label to see if you are taking Brompheniramine Tannate Suspension is made by ANIP, labeled with the product number NDC 62559-6291-4. You can also look for the lot numbers FBS001, FBS002, HBS001, and HBS002 on the bottle but often pharmacies do not dispense suspensions in the manufacturer's original bottle and the pharmacy bottle may not have the lot number printed on it. If you think your Brompheniramine Tannate Suspension may be involved in the recall or if you do not know, please return your bottle to your pharmacist to examine and possibly exchange.

If you have any questions or concerns about this recall, please follow up with your doctor or pharmacist. If you think you may be experiencing side effects from your Brompheniramine Maleate, please contact your doctor as soon as possible.

Recall of Several Lots of Brompheniramine Tannate Suspension

ANIP Acquisition Co. is recalling several lots of BrompheniramineTannate Suspension 4 ounce (oz) bottles containing Brompheniramine Tannate, 12 mg per 5 mL. This recalled product has the product number NDC 62559-6291-4 and is only available by prescription. Lot numbers FBS001, FBS002, HBS001, and HBS002 are being recalled because this product has not been reviewed and approved by the FDA for safety and efficacy.

Brompheniramine Tannate is a medicine that is commonly used to treat runny nose, sneezing, and itchy, watery eyes caused by allergies, a cold or the flu.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-11-20
Last Updated: 2009-12-05

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