Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
Class I - DangerousWhat Should You Do?
- Check if you have this product: [Case of 40] Lots 183723, 184278, exp 10/31/2020; Lot 187652, exp 05/31/2021; [Case of 50] Lot 177874, exp 01/31/ 2020; Lot 178413, exp 02/29/ 2020; Lot 183449, exp 10/31/2020; Lot 184445, exp 12/31/ 2020; Lot 186563, exp 03/31/ 2021; Lot 187691, exp 05/31/2021
- 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:
- American Health Packaging
- Reason for Recall:
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
Product Codes/Lot Numbers:
[Case of 40] Lots 183723, 184278, exp 10/31/2020; Lot 187652, exp 05/31/2021; [Case of 50] Lot 177874, exp 01/31/ 2020; Lot 178413, exp 02/29/ 2020; Lot 183449, exp 10/31/2020; Lot 184445, exp 12/31/ 2020; Lot 186563, exp 03/31/ 2021; Lot 187691, exp 05/31/2021
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0631-2020
Related Recalls
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Impurity failure at 0-time of the repackaged lot.