Key Takeaway

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79 by AuroMedics Pharma LLC was recalled on September 23, 2019. The hazard: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

FDA Drug Class III Ongoing

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

Recalled: September 23, 2019 ~69696 bottles units affected D-0166-2020

Description

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

Hazard / Reason

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

Drugs

Company Information

AuroMedics Pharma LLC

East Windsor, NJ, United States

View all 36 recalls by AuroMedics Pharma LLC →

Distribution

Nationwide within the United States

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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.