Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
- 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:
- Amneal Pharmaceuticals, Inc.
- Reason for Recall:
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Product Codes/Lot Numbers:
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0614-2020
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