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10/5/03 at 2:07pm
Thread Starter 
(SafetyAlerts) - The FDA has released the following information.

PRODUCT
Duradryl Jr. Capsules, Each T.D. Capsule contains: (Phenylephrine HCl 10mg, Chlorpheniramine Maleate 4.0mg, Methscopolamine Nitrate 1.25mg), 100 Capsule bottles, Rx Only, Dist. by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. NDC 51991-700-01 Recall # D-329-3.

CODE
Lot No. 046G3002.

RECALLING FIRM/MANUFACTURER
Nutramed, Inc., Rahway, NJ, by letter on July 24, 2003. Firm initiated recall is ongoing.

REASON
Dissolution failure; Phenylephrine HCI and Methscopolamine Nitrate.

VOLUME OF PRODUCT IN COMMERCE
4,992 bottles.

DISTRIBUTION
Nationwide.
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