FDAFDA · Food and drugs·Recall number D-0184-2020
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC
Published November 13, 2019 · Recall initiated: October 1, 2019
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
- Lot
- Batch Numbers: All lots within expiry.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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