Lortuss EX recall
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.…
Why was Lortuss EX recalled?
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 03613, Expiry: 02/15
- Product
- 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.…
- Recalling firm
- Poly Pharmaceuticals, Inc
- Quantity
- 102 Bottles
- Distribution
- U.S. Nationwide
- Recall date
- July 23, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)