Ranitidine Hydrochloride Capsule
FDA Recall NDC 55111-129
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ranitidine Hydrochloride (NDC 55111-129). A significant event, classified as Class II, was initiated on Oct 01, 2019 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "CGMP Deviations: Presence of NDMA impurity detected in product."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP Deviations: Presence of NDMA impurity detected in product.
Oct 01, 2019
Nov 13, 2019
N/A
Recall Profile & Regulatory Data
Event ID
83908
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description
Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)
Batch or Lot Expiration Information
Lot# Batch Numbers: All lots within expiry.
Affected Packages Involved in this Recall
55111-129-60Product
55111-129-05Product
55111-130-30Product
55111-130-01Product
Class II Completed
CGMP Deviations: Presence of NDMA impurity detected in product.
Oct 01, 2019
Nov 13, 2019
N/A
Recall Profile & Regulatory Data
Event ID
83908
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description
Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)
Batch or Lot Expiration Information
Lot# Batch Numbers: All lots within expiry.
Affected Packages Involved in this Recall
55111-129-60Product
55111-129-05Product
55111-130-30Product
55111-130-01Product
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.
