RANITIDINE

Generic: RANITIDINE

Dr. Reddy's Laboratories LimitedManufacturer
ORALRoute
RANITIDINE HYDROCHLORIDEActive Substance
2000-03-28Original Approval

RANITIDINE is FDA application ANDA075294, sponsored by DR REDDYS LABS LTD. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2019-12-13
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

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

Class II2019-11-22
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

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

Class II2019-10-01
Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-12

CGMP Deviations: Presence of NDMA impurity detected in product.

Class II2019-10-01
Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class II2019-11-22
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

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

Class II2019-10-01
Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class II2019-10-01
Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-13

CGMP Deviations: Presence of NDMA impurity detected in product.

Top Reported Reactions

1
BREAST CANCER
29,412 reports
2
PROSTATE CANCER
26,445 reports
3
COLORECTAL CANCER
20,720 reports
4
BLADDER CANCER
19,207 reports
5
RENAL CANCER
19,035 reports
6
OESOPHAGEAL CARCINOMA
11,066 reports
7
INCORRECT DOSE ADMINISTERED
9,743 reports
8
HEPATIC CANCER
8,834 reports
9
GASTRIC CANCER
8,742 reports
10
PANCREATIC CARCINOMA
8,037 reports