Spectrum Laboratory Products recalls Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100
Recalled February 12, 2020 · FDA recall D-0825-2020 · Spectrum Laboratory Products
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product. · FDA Class II
Units
N/A
Sold at
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.
Description
CGMP Deviations: Presence of NDMA impurity detected in product.
Product
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
Manufacturer(s)
Spectrum Laboratory Products
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →