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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 30, 1999

Signature Pharmaceuticals, Inc. Recalls Prescription Cough Syrups

Gloversville, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Signature Pharmaceuticals, Inc. is recalling 4 kinds of prescription cough syrups because there is a lack of data to support labeled expiration date.

PRODUCT
Rx controlled-substance cough syrups:
a) ENDOTUSS HD(tm) Syrup, (Hydrocodone Bitartrate 1.67 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg), in one pint (473 mL) bottles
b) POLYTINE D(tm) Syrup, (Phenylpropanolamine Hydrochloride 12.5 mg, Phenyltoloxamine Citrate 4 mg, Pyrilamine Maleate 4 mg, Pheniramine Maleate 4 mg, Alcohol 4%), in one pint (473mL) bottles
c) POLYTINE CS (tm) Syrup, (Codeine Phosphate 10 mg, Phenylpropanolamine Hydrochloride 12.5 mg, Brompheniramine Maleate 2 mg), in one pint (473 mL) bottles
d) CO-TUSSIN(tm) Syrup, (Hydrocodone Bitartrate 5 mg, Guaifenesin 100 mg) in one pint (473 mL ) bottles, all lot numbers.

Recall #D-269/271-9 and D-273-9.

CODE (lot number and expiration date)
a) NDC 58634-0004-1 (EndoTuss HD)
AA146, 09/2000
AA152, 09/2000
AA159, 11/2000
AA164R, 12/2000
AA170, 2/2001
AA173, 3/2001
b) NDC 58634-0010-1 (Polytine D)
AA153, 9/2000
AA156, 10/2000
AA163, 11/2000
AA169, 3/2001
c) NDC 58634-0009-1 (Polytine CS)
AA154, 10/2000
AA160, 11/2000
AA166, 1/2001
AA177, 3/2001
d) NDC 58634-0032-1 (CoTussin)
AA161, 11/2000
AA162, 12/2000
AA165, 12/2000
AA168, 2/2001
AA172, 3/2001
AA174, 3/2001.

MANUFACTURER
Signature Pharmaceuticals, Inc., Gloversville, New York.

RECALLED BY
Manufacturer, by letter dated June 8, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a) EndoTuss HD: 16,165/one pint (473 ml) bottles
b) Polytine D: 9,103/one pint (473 ml) bottles
c) Polytine CS: 5,293/one pint (473 ml) bottles
d) CoTussin: 13,410/one pint (473 ml) bottles were distributed.

 

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.