Drug 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

D-0825-2020

January 14, 2020

Class II

Product summary

Firm: Spectrum Laboratory Products
Event: Event 84799
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-0825-2020

Official wording

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

Code information: Lot #:11E0585, Exp. October 2023

Distribution pattern: 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.

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

NDMA impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations