FDAFDA · Food and drugs·Recall number D-0617-2020
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Published December 18, 2019 · Recall initiated: December 2, 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: Presence of NDMA impurity detected in product.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Distributor
- CA, FL
- Lot
- Lot #: I2519H, Exp. 12/20; I2719O, Exp. 12/20; J1419O, Exp. 12/20; J2819L, Exp. 12/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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