Multi-event October 2019 FDA Recall Ranitidine Hydrochloride by Dr. Reddy's Laboratories, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on October 1, 2019 for the product Ranitidine Hydrochloride. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to major distributors throughout the United States who may have further distributed the product. and the recall is currently completed.

Reported Recall Events

D-0171-2020 COMPLETED D-0172-2020 COMPLETED D-0168-2020 COMPLETED D-0180-2020 COMPLETED D-0175-2020 COMPLETED D-0179-2020 COMPLETED D-0174-2020 COMPLETED D-0184-2020 COMPLETED D-0185-2020 COMPLETED D-0169-2020 COMPLETED D-0170-2020 COMPLETED D-0173-2020 COMPLETED D-0178-2020 COMPLETED D-0182-2020 COMPLETED D-0177-2020 COMPLETED D-0183-2020 COMPLETED D-0176-2020 COMPLETED D-0181-2020 COMPLETED

Recall Number: D-0171-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0172-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0168-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
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

55111-129-60 Ranitidine Hydrochloride
55111-129-05 Ranitidine Hydrochloride
55111-130-30 Ranitidine Hydrochloride
55111-130-01 Ranitidine Hydrochloride

Recall Number: D-0180-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
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

55111-129-60 Ranitidine Hydrochloride
55111-129-05 Ranitidine Hydrochloride
55111-130-30 Ranitidine Hydrochloride
55111-130-01 Ranitidine Hydrochloride

Recall Number: D-0175-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0179-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0174-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0184-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0185-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0169-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0170-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0173-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0178-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0182-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Affected Packages Involved in this Recall

55111-404-34 Ranitidine
55111-404-32 Ranitidine
55111-404-36 Ranitidine
55111-404-50 Ranitidine
55111-404-61 Ranitidine
55111-404-55 Ranitidine
55111-404-62 Ranitidine
55111-404-90 Ranitidine
55111-404-02 Ranitidine
55111-404-65 Ranitidine
55111-404-17 Ranitidine
55111-404-24 Ranitidine
55111-404-38 Ranitidine
55111-404-40 Ranitidine

Recall Number: D-0177-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0183-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0176-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Recall Number: D-0181-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
10-01-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83908
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Product Description About Product Description
Full technical description of the product.
Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

Batch or Lot Expiration Information

Lot# Batch Numbers: All lots within expiry.

Affected Packages Involved in this Recall

55111-131-30 Ranitidine
55111-131-60 Ranitidine
55111-131-80 Ranitidine
55111-131-90 Ranitidine
55111-131-04 Ranitidine
55111-131-37 Ranitidine
55111-131-79 Ranitidine
55111-131-14 Ranitidine
55111-131-81 Ranitidine
55111-131-45 Ranitidine