Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: 503670
- 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:
- Precision Dose Inc.
- Reason for Recall:
- cGMP Deviations: Product manufactured with contaminated raw ingredient.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Product Codes/Lot Numbers:
Lot#: 503670
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0094-2022
Related Recalls
cGMP Deviations: Product manufactured with contaminated raw ingredient.
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.