Recall record at a glance
| Official record | D-1431-2014 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Poly Pharmaceuticals, Inc. |
| Report date | Jul 23, 2014 |
| Recall initiation date | Jun 26, 2014 |
| Quantity | 208 Bottles |
| Location | Owens Cross Roads, AL, United States |
Official product description
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.
Why the product was recalled
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Distribution information
U.S. Nationwide
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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