Drug 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.
D-1431-2014
Product summary
- Event
- Event 68671
- Status
- Terminated
- Classification
- Class III
- Quantity
- 208 Bottles
- Official record key
drug-enforcement:D-1431-2014
Official wording
Reason: Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Code information: Lot #: 04413, Expiry: 02/15
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Unknown
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".