Key Takeaway

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25). by Amneal Pharmaceuticals, Inc. was recalled on November 22, 2019. The hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

FDA Drug Class II Ongoing

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

Recalled: November 22, 2019 ~N/A units affected D-0613-2020

Description

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

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 Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

Drugs

Company Information

Amneal Pharmaceuticals, Inc.

Brookhaven, NY, United States

View all 10 recalls by Amneal Pharmaceuticals, Inc. →

Distribution

Product was distributed throughout the United States.

Related Recalls

FDA Drug Class II

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

November 22, 2019
FDA Drug Class II

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

November 22, 2019
FDA Drug Class II

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e

November 22, 2019
FDA Drug Class II

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

November 22, 2019
FDA Drug Class III

Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3

October 16, 2019
FDA Drug Class III

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

September 24, 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.