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

Recall Number: D-0825-2020

Firm: Spectrum Laboratory Products

Classification: Class II

Status: Terminated

Report Date: 20200212

Initiation Date: 20200114

Termination Date: 20231205

CGMP Deviations: Presence of NDMA impurity detected in 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