FDAFDA · Food and drugs·Recall number D-0016-2021
Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Published October 14, 2020 · Recall initiated: January 15, 2020
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: Presence of NDMA impurity detected in product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Direct Rx
- Distributor
- FL, GA
- Lot
- Lots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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