FDA-Drug2020-01-15Class II

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

AAA Pharmaceutical, Inc.
Hazard

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Sold states
Product was distributed to one consignee who may have distributed the product further to their retail stores.
Affected count
31,536 (130-count bottles)
Manufactured in
681 Main St, N/A, Lumberton, NJ, United States
Products
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2020

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