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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January 20, 1999

PRODUCT
a) Extendryl SR Extended-Release Capsules (chlorpheniramine maleate 8mg/phenylephrine HCL 20 mg/methscopolamine nitrate 2.5mg), in 100 capsules. NDC #0256-0111-01; b) Extendryl JR Extended-Release Capsules (chlorpheniramine maleate 5mg/phenylephrine HCL 10 mg/methscopolamine nitrate 1.25 mg), in 100 capsule bottles. NDC #0256-0177-01. Both products are Rx for the relief of respiratory congestion, allergic rhinitis, vasomotor rhinitis, and allergic skin reactions of urticaria and angioedema. Recall #D-091/092-9.

CODE
Lot numbers: 8083633, 8091637, 8092634, 8091636.

MANUFACTURER
Fleming and Company, Fenton, Missouri.

RECALLED BY
Manufacturer, by telephone the latter part of the week of November 30, 1998, followed by letter on or about December 1, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
6,418 units were distributed.

REASON
Mislabeling - Inserts are incorrectly printed with both sides the same.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.