Why it was recalled
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Product description
LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.
Lot numbers, UPCs & expiration codes
Lot #: 03613, Expiry: 02/15
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1432-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 26, 2014
- FDA report date
- Jul 23, 2014
- Quantity
- 102 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Poly Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-1432-2014, exactly as published.
Show all FDA fields
- City
- Owens Cross Roads
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 68671
- Address
- 2720 Cullom Blvd Se
- Code information
- Lot #: 03613, Expiry: 02/15
- Postal code
- 35763-9309
- Report date
- Jul 23, 2014
- Product type
- Drugs
- Recall number
- D-1432-2014
- Classification
- Class III
- Recalling firm
- Poly Pharmaceuticals, Inc
- Product quantity
- 102 Bottles
- Termination date
- Nov 3, 2014
- Reason for recall
- Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jun 26, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 11, 2014