FDA-Drug2019-12-04Class II

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

AuroMedics Pharma LLC
Hazard

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

Sold states
nationwide
Affected count
45,456 bottles
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0527-2020

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