Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot number: 500105, Exp 04/30/18
- 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:
- Subpotent Drug: low out of specification results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
Product Codes/Lot Numbers:
Lot number: 500105, Exp 04/30/18
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0057-2018
Related Recalls
cGMP Deviations: Product manufactured with contaminated raw ingredient.
cGMP Deviations: Product manufactured with contaminated raw ingredient.
cGMP deviations: The firm was notified of the manufacturer's expanded recall.