Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 914227; Exp 06/16
- 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:
- Safecor Health, LLC
- Reason for Recall:
- Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.
Product Codes/Lot Numbers:
Lot #: 914227; Exp 06/16
Distribution:
Distributed in: NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0785-2016
Related Recalls
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.