FDAFDA · Food and drugs·Recall number D-0529-2020
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
Published December 4, 2019 · Recall initiated: November 6, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- nationwide
- Lot
- UI1519001-A UI1519002-A UI1519003-A UI1519004-A
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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