Ranitidine Tablet
FDA Recall NDC 62207-774
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ranitidine (NDC 62207-774). A significant event, classified as Class II, was initiated on Dec 13, 2019 by Granules India Ltd. The reported reason for this action was: "CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Dec 13, 2019
Jan 08, 2020
23,090,000 tablets
Recall Profile & Regulatory Data
Event ID
84522
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Granules India Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OR, NY, NJ
Product Description
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Batch or Lot Expiration Information
Lot# 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
Affected Packages Involved in this Recall
62207-774-58Product
62207-774-41Product
62207-774-47Product
62207-774-36Product
62207-773-58Product
62207-773-41Product
62207-773-47Product
62207-773-32Product
62207-773-36Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
