PlainRecalls
FDA Drug Moderate Class II Ongoing

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

Reported: December 4, 2019 Initiated: November 6, 2019 #D-0526-2020

Product Description

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

Reason for Recall

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Details

Recalling Firm
AuroMedics Pharma LLC
Units Affected
69,696 bottles
Distribution
nationwide
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79. Recalled by AuroMedics Pharma LLC. Units affected: 69,696 bottles.
Why was this product recalled?
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 4, 2019. Severity: Moderate. Recall number: D-0526-2020.