Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Class I - DangerousWhat Should You Do?
- Check if you have this product: P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 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:
- AAA Pharmaceutical, 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:
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Product Codes/Lot Numbers:
P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0646-2020
Related Recalls
Labeling: Incorrect or Missing Lot and/or Expiration date.
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
AAA Pharmaceutical
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.