Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenes...
FDA Drug Recall #D-1097-2014 — Class III — February 4, 2014
Recall Summary
| Recall Number | D-1097-2014 |
| Classification | Class III — Low risk |
| Date Initiated | February 4, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Aaron Industries Inc |
| Location | Lynwood, CA |
| Product Type | Drugs |
| Quantity | 43,921 bottles |
Product Description
Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.
Reason for Recall
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Distribution Pattern
Nationwide
Lot / Code Information
Lot #: 151631, Exp 10/15 and 152767, Exp 11/15
Other Recalls from Aaron Industries Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1286-2014 | Class III | Maximum Strength/Non-Drowsy Tussin DM Adult Max... | Apr 11, 2014 |
| D-419-2013 | Class III | Rite Aid brand Maximum Strength Tussin Cough & ... | Apr 4, 2013 |
| D-186-2013 | Class III | Rite Aid Maximum Strength Tussin Cough & Cold M... | Jan 18, 2013 |
| D-187-2013 | Class III | Select Brand Cough Control CF Max, Maximum Stre... | Jan 18, 2013 |
| D-188-2013 | Class III | Wal-Mart Equate Tussin CF Adult Maximum Strengt... | Jan 18, 2013 |
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.