Children's Pain & Fever Concentrated Drops
Class I - DangerousWhat Should You Do?
- Check if you have this product: (About 898,000)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Altaire Pharmaceuticals, Inc., of Aquebogue, N.Y
- Reason for Recall:
- This over the counter medicine contains acetaminophen which calls for child-resistant packaging as required by the Poison Prevention Packaging Act. Although the original bottle has child-resistant packaging, a separate dropper unit provided for dispensing the drug to children does not. When in use, a child can access the medicine, posing serious health problems or death if more than the recommended dosage is consumed.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
- Hazard:
- This over the counter medicine contains acetaminophen which calls for child-resistant packaging as required by the Poison Prevention Packaging Act. Although the original bottle has child-resistant packaging, a separate dropper unit provided for dispensing the drug to children does not. When in use, a child can access the medicine, posing serious health problems or death if more than the recommended dosage is consumed.
- Remedy:
- Consumers should immediately store this product with the child-resistant closure in place and keep it out of the reach of children. To arrange for a free replacement dropper, contact Altaire Pharmaceuticals at (800) 258-2471 9 a.m. to 5 p.m. ET Monday through Friday.
Product Images
Product Information
Full Description:
The recall involves Rugby Children's Pain & Fever Concentrated Drops (Acetaminophen Drops) in a 1/2 fl. oz. (15 ml) bottle size. The UPC code 305361936723 can be found with the bar code at the bottom of the box. The affected lot numbers are: 09002 09379 10272 10368 10487 09131 09394 10273 10406 11058 09215 10154 10366 10433 The lot numbers can be found stamped into the bottom of the carton with the expiration date and above the label on the bottle printed in black.
Product Codes/Lot Numbers:
(About 898,000)
Official Source
Always verify recall information with the official CPSC source:
View on CPSC.govCPSC Recall Number: 11258