Key Takeaway

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC. by Dr. Reddy's Laboratories, Inc. was recalled on October 1, 2019. The hazard: CGMP Deviations: Presence of NDMA impurity detected in product.

FDA Drug Class II Completed

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

Recalled: October 1, 2019 ~N/A units affected D-0178-2020

Description

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

Hazard / Reason

CGMP Deviations: Presence of NDMA impurity detected in product.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

Drugs

Company Information

Dr. Reddy's Laboratories, Inc.

Bridgewater, NJ, United States

View all 163 recalls by Dr. Reddy's Laboratories, Inc. →

Distribution

Product was distributed to major distributors throughout the United States who may have further distributed the product.

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.