FDAFDA · Food and drugs·Recall number D-0128-2020
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
Published October 16, 2019 · Recall initiated: September 23, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Sandoz, Inc
- Distributor
- U.S. Nationwide
- Lot
- HD1862 4/30/2020 HP9438 9/30/2020 HP9439 9/30/2020 HP9440 9/30/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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