FDAFDA · Food and drugs·Recall number D-0825-2020
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
Published February 12, 2020 · Recall initiated: January 14, 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
- Spectrum Laboratory Products
- Distributor
- The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.
- Lot
- Lot #:11E0585, Exp. October 2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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