Why it was recalled
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Product description
Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Rite-Aid, Camp Hill, PA 17011, NDC 11822-0419-1; c) Topcare, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-419-26; d) Kroger, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: The Kroger Co., Cincinnati, OH 46202, NDC 30142-419-26; e) GoodSense, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: Perrigo, Allegan, MI 49010, NDC 0113-0419-26; f) Dollar General, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: DolgenCorp, LLC, Goodlettsville, TN 37072, NDC 55910-419-26; g) Care One, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Gluten Free, Distributed by: American Sales Company, Lancaster, NY 14086, NDC 41520-419-26; h) CVS, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: CVS Pharmacy Inc, Woonsocket, RI 02895.
Lot numbers, UPCs & expiration codes
Lot #s: 5LK0528, 5LK0630, 5LK0779, Exp 03/17
Where it was sold
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-0587-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 8, 2016
- FDA report date
- Feb 3, 2016
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-0587-2016, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 73044
- Address
- 515 Eastern Ave
- Code information
- Lot #s: 5LK0528, 5LK0630, 5LK0779, Exp 03/17
- Postal code
- 49010-9070
- Report date
- Feb 3, 2016
- Product type
- Drugs
- Recall number
- D-0587-2016
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Termination date
- May 18, 2016
- Reason for recall
- Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Rite-Aid, Camp Hill, PA 17011, NDC 11822-0419-1; c) Topcare, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-419-26; d) Kroger, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: The Kroger Co., Cincinnati, OH 46202, NDC 30142-419-26; e) GoodSense, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: Perrigo, Allegan, MI 49010, NDC 0113-0419-26; f) Dollar General, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: DolgenCorp, LLC, Goodlettsville, TN 37072, NDC 55910-419-26; g) Care One, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Gluten Free, Distributed by: American Sales Company, Lancaster, NY 14086, NDC 41520-419-26; h) CVS, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: CVS Pharmacy Inc, Woonsocket, RI 02895.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 8, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 22, 2016