FDA-Drug2020-02-12Class II
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
Spectrum Laboratory Products
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
Sold states
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.
Affected count
N/A
Manufactured in
14422 S San Pedro St, N/A, Gardena, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0825-2020Don't want to check this manually?
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