Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packag...
FDA Drug Recall #D-0587-2016 — Class II — January 8, 2016
Recall Summary
| Recall Number | D-0587-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 8, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Perrigo Company PLC |
| Location | Allegan, MI |
| Product Type | Drugs |
| Quantity | N/A |
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.
Reason for Recall
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Distribution Pattern
Nationwide
Lot / Code Information
Lot #s: 5LK0528, 5LK0630, 5LK0779, Exp 03/17
Other Recalls from Perrigo Company PLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0623-2022 | Class II | No Drip Nasal Spray, Oxymetazoline HCl 0.05% Na... | Oct 26, 2021 |
| D-0601-2022 | Class II | Acetaminophen Child Bubble Gum Flavored Oral Su... | Oct 26, 2021 |
| D-0607-2022 | Class II | Severe Congestion Nasal Spray, No Drip Plus Men... | Oct 26, 2021 |
| D-0580-2022 | Class II | Children's Pain & Fever Bubblegum Flavored Ace... | Oct 26, 2021 |
| D-0624-2022 | Class II | Maximum Strength No Drip Nasal Spray, Oxymetazo... | Oct 26, 2021 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.