Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
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
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
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
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
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
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Completed
Historical recordClass II
Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- October 1, 2019
- Reported by FDA
- November 13, 2019
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Recall initiated
- September 27, 2019
- Reported by FDA
- November 6, 2019
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Ongoing
Historical recordClass III
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
by AuroMedics Pharma LLC
- Reason
- CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
- Recall initiated
- September 23, 2019
- Reported by FDA
- November 6, 2019
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
by Innoveix Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance.
- Recall initiated
- October 10, 2019
- Reported by FDA
- November 6, 2019
- Distribution
- Nationwide within the United States
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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