Key Takeaway

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. by AAA Pharmaceutical, Inc. was recalled on December 26, 2019. The hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

FDA Drug Class II Terminated

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

Recalled: December 26, 2019 ~31,536 (130-count bottles) units affected D-0646-2020

Description

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

Hazard / Reason

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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 150 mg tablets, 130 count bottles, NDC 37808-196-04.

Drugs

Company Information

AAA Pharmaceutical, Inc.

Lumberton, NJ, United States

View all 4 recalls by AAA Pharmaceutical, Inc. →

Distribution

Product was distributed to one consignee who may have distributed the product further to their retail stores.

Related Recalls

FDA Drug Class III

Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7;

February 14, 2020
FDA Drug Class II

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

December 26, 2019
FDA Drug Class III

Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83967-38786-1 bottles, Distributed by: Kmart Corporation Hoffman Estates, IL 60179

June 25, 2019

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.