FDA recall D-0825-2020

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.

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.

Key facts

Status

Terminated

Initiation date

2020-01-14

Report date

2020-02-12

Termination date

2023-12-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gardena, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0825-2020