Class III
Terminated
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.
This recall has been terminated (originally issued July 23, 2014).
- Company
- Poly Pharmaceuticals, Inc
- Recall Initiated
- June 26, 2014
- Posted
- July 23, 2014
- Recall Number
- D-1431-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 208 Bottles
- Firm Location
- Owens Cross Roads, AL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Distribution
U.S. Nationwide
Lot / Code Info
Lot #: 04413, Expiry: 02/15
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