drugs Class III Updated 2014-07-23

Poly Pharmaceuticals, Inc recalls POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: B

Recalled Product

POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16.

Hazard / Issue

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 04413, Expiry: 02/15
View official government recall

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