FDA Drug Moderate Class II Terminated

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

Reported: February 12, 2020 Initiated: January 14, 2020 #D-0825-2020

Product Description

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Details

Recalling Firm: Spectrum Laboratory Products
Units Affected: N/A
Distribution: 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.
Location: Gardena, CA

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Spectrum Laboratory Products. Units affected: N/A.

Why was this product recalled? ▼

CGMP Deviations: Presence of NDMA impurity detected in product.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on February 12, 2020. Severity: Moderate. Recall number: D-0825-2020.