Safety Alerts & Recalls

What does this mean?

At this time, there have been no reports of problems with this recalled lot number of Brompheniramine Phenylephrine 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 your Brompheniramine Phenylephrine Tannate Suspension is made by ANIP and is labeled with the product number NDC 62559-6331-6. You can also look for the lot number FBP010, but often pharmacies do not dispense suspensions in the manufacturer's original bottle and the pharmacy bottle will not have the lot number printed on it. If you think your Brompheniramine Phenylephrine 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 with Phenylephrine, please contact your doctor as soon as possible.

Recall of a Single Lot of Brompheniramine Phenylephrine Tannate Suspension

ANIP Acquisition Co. is recalling a single lot of Brompheniramine Phenylephrine Tannate Suspension 16 ounce (473 mL) bottles containing Phenylephrine Tannate, 20 mg and Brompheniramine Tannate, 12 mg per 5 mL. This recalled product has the product number NDC 62559-6331-6 and is only available by prescription. The lot number FBP010 is being recalled because this product has not been reviewed and approved by the FDA for safety and efficacy.

Brompheniramine Phenylephrine Tannate is a medicine that is commonly used to treat nasal congestion and runny nose symptoms caused by allergies or 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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