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
Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: 20200114
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated