FDA recall D-0641-2020

Product

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

Natiowide

Key facts

Status

Ongoing

Initiation date

2019-12-17

Report date

2020-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0641-2020