Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-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:
- Appco Pharma LLC
- 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:
- terminated
Product Information
Full Description:
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
Product Codes/Lot Numbers:
Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0648-2020
Related Recalls
Class I - Dangerous
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API