AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 17709 Exp.01/31/2020 Lot 18460 Exp.02/29/2020 Lot 19853 Exp.09/30/2020 Lot 22362 Exp.11/30/2020 Lot 22579 Exp.11/30/2020
- 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:
- AVKARE 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:
- terminated
Product Information
Full Description:
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Product Codes/Lot Numbers:
Lot 17709 Exp.01/31/2020 Lot 18460 Exp.02/29/2020 Lot 19853 Exp.09/30/2020 Lot 22362 Exp.11/30/2020 Lot 22579 Exp.11/30/2020
Distribution:
Distributed in: CO, MO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0165-2020
Related Recalls
Failed Content Uniformity Specifications
Class I - Dangerous
Presence of a foreign substance.
Class I - Dangerous
Presence of a foreign substance.