FDA-Drug2019-12-04Class II
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
AuroMedics Pharma LLC
Hazard
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Sold states
nationwide
Affected count
19320 bottles
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0529-2020Don't want to check this manually?
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